JP2021530306A - To improve the visibility of the body lumen and / or the side wall of the body cavity and / or to operate the side wall to achieve improved access to the side wall, and / or to stabilize the instrument relative to the side wall. Method and equipment for - Google Patents

Abstract

A device for endoscopically retracting tissue, with a sleeve fitted to slide over the outer portion of the endoscope; with a balloon movably placed on the sleeve; It comprises at least one connector extending from the balloon, configured to be anchored to the tissue to be retracted, and configured to allow the balloon to be moved relative to the sleeve to retract the tissue. [Selection Diagram] FIG. 61.

Description

(See pending prior patent application)
This patent application is:
(1) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" Part of the pending prior U.S. Patent Application No. 16 / 477,789 (agent reference number CORN-43 PCT US) filed on July 12, 2019 by Cornell University and Jeffrey Milsom et al. This is a continuation application, and this (1) is
(I) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" Article 371 of the International (PCT) Patent Application PCT / US18 / 13894 (Agent Reference Number CORN-43 PCT) filed on January 16, 2018 by Cornell University and Jeffrey Milsom et al. This is a domestic transition procedure based on this (i).
(A) "BALLOON TISSUE RETRATION USING HOOP AND CLIP WITH VARIABLE LENGTH CAPABILITY, WITH SPECIMEN RETRIEVAL POUCH IN BALLOON" Patent application No. 62 / 446,167 (agent reference number CORN-43 PROV); and (b) filed on February 22, 2017 by Cornell University and Jeffrey Milsom et al., entitled "BALLOON SPECIMEN RETRIEVAL". It claims the interests of the preceding US provisional patent application No. 62 / 462,241 (agent reference number CORN-41 PROV), where (1) is:
(Ii) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" Part of the pending prior U.S. Patent Application No. 16 / 000,104 (agent reference number CORN-34 CON) filed June 5, 2018 by Cornell Visualization and John Frederick Cornhell et al. This is a continuation application, and this (ii) is
Entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", This is a partial continuation of the preceding US Patent Application No. 14 / 619,845 (agent reference number CORN-34) filed on February 11, 2015 by Cornell Visualization and John Frederick Cornell et al. The application is
(A) "METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND / OR FLATTENING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SIDE WALL OF THE BODY LUMEN OR BODY CAVITY, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME, by Jeffrey Milsom et al., Of the preceding US provisional patent application No. 61 / 284,215 (agent reference number CORN-17 PROV) filed on December 15, 2009. is a patent application claiming the benefit "METHOD aND APPARATUS fOR STABILIZING, sTRAIGHTENING, EXPANDING aND / OR FLATTENING tHE SIDE WALL oF a BODY LUMEN aND / OR BODY CAVITY SO aS tO PROVIDE INCREASED VISUALIZATION oF tHE SAME aND / OR INCREASED ACCESS tO tHE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME ”by Jeffrey Milsom et al., Prior US Patent Application No. 12 / 969,059 (agent reference number) filed on December 15, 2010. CORN-17) which is a continuation-in-part application of "METHOD aND APPARATUS fOR STABILIZING, sTRAIGHTENING, EXPANDING aND / OR FLATTENING tHE SIDE WALL oF a BODY LUMEN aND / OR BODY CAVITY SO aS tO PROVIDE INCREASED VISUALIZATION oF tHE SAME aND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENT Prior US Patent Application No. 14 / 540,355 filed on November 13, 2014 by Cornell University and Jeffrey Milsom et al., entitled "S RELATIVE TO THE SAMME" (agent reference number CORN-17 CON). )
(B) "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUAL Prior US Provisional Patent Application No. 61 / 938, 446, filed on February 11, 2014, by Cornell University and John Frederick Cornhell et al., entitled "STABILIZING INSTRUMENTS RELATIVE TO THE SAME". -34 PROV)
Claims the interests of
In addition, this patent application is
(2) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" Lumendi Ltd. And Peter Johann et al. Claim the interests of the pending preceding US Provisional Patent Application No. 62 / 698,583 (agent reference number LUMENDI-20 PROV) filed on July 16, 2018. ..

The 11 patent applications shown above are incorporated herein by reference.

The present invention relates generally to surgical methods and devices, and more specifically to improving visibility of body lumens and / or side walls of body cavities and / or improving access to the side walls. With respect to surgical methods and devices for manipulating and / or stabilizing the instrument relative to the sidewall.

The human body has many different body cavities and cavities. For example, the human body has body lumens such as gastrointestinal (GI) tubes, blood vessels, lymph vessels, urinary tracts, fallopian tubes, bronchi, and bile ducts. As a further example, but not limited to, the human body includes body cavities such as the head, chest, abdomen, nasal sinuses, bladder, cavities within organs, and the like.

In many cases, it may be desirable to endoscopically examine and / or treat the course or abnormality of the disease seen in or on the side walls of the body lumen and / or body lumen. For example, examining the side wall of the gastrointestinal tract for a lesion and, if found, performing a biopsy on the lesion, removing the lesion, and / or treating the lesion in some other way. May be desirable.

By the anatomical structure of the body cavity and / or the side wall of the body cavity (both local and local) and / or by the stiffness of the tissue that forms the side wall of the body cavity and / or the body cavity. And / or endoscopy and / or endoscopy of the body cavity and / or the side wall of the body cavity by tethering the body cavity and / or the side wall of the body cavity to other anatomical structures. Mirror treatment can be complicated.

For example, the intestine is an elongated tubular organ with an inner lumen, characterized by many turns (ie, the local anatomical structure of the intestine), and with numerous folds. It has a characteristic side wall (ie, the local anatomical structure of the intestine), the side wall tissue has a relatively soft and bendable stiffness, especially the colon through the soft tissue in the abdomen and / or other abdomen. It is connected to the structure. Because of this changing lateral wall anatomy (both local and local), its relatively soft and bendable stiffness, and its junction with other anatomical structures through soft tissue. It can be difficult to fully visualize the intestinal sidewalls and / or treat lesions that form on the intestinal sidewalls. For example, in the case of colonoscopy, about 5-40% of patients use conventional endoscopes for anatomy (including the pathological condition of the anatomy, such as polyps or tumors), but not limited to it. Side wall anatomy that makes it difficult to fully visualize and / or makes it difficult to fully access the anatomy using instruments introduced through conventional endoscopes. It has a specific composition (local and / or local) and / or tissue stiffness and / or a colonic junction to other anatomical structures.

In addition to the above, it has been found that some body cavities and / or body cavities can convulsions and / or contract. This spasm and / or contraction can occur spontaneously, but is especially likely when an endoscope or other instrument is inserted into the body cavity and / or body cavity. This spasm and / or contraction can narrow and / or otherwise move and / or alter its composition of the body lumen and / or body cavity, thereby providing an endoscopic visualization of the biological structure. It can be more complex and / or of poor quality, and / or more complicated and / or further access to the biostructure using instruments introduced through conventional flexible endoscopes. May be of poor quality. In addition, during the colon examination, which is usually done both when inserting and retracting the endoscope through the colon, the endoscope grips and / or otherwise forms the colon during insertion and / or withdrawal. It may be gathered together and then suddenly moved to release the colon. This squeezing and sudden release of the colon causes the endoscope to move quickly to pass a considerable length of the colon, which makes it difficult to accurately examine the colon. become.

Therefore, the body aims to better present the side wall tissue for examination and / or treatment during an endoscopic procedure, including visualization of areas initially hidden from or outside the field of view. It is very advantageous to provide a novel device capable of manipulating the side walls of the lumen and / or body cavity.

Also, instruments that are inserted into the body lumen and / or the body cavity with reference to the body lumen and / or the side wall of the body cavity (eg, an endoscope, a grasper, a cutter or anatomical instrument, a cauterizing tool, or an ultrasound. It is very advantageous to provide a novel device capable of fixing and / or stabilizing the distal tip and / or working end of an articulated and / or non-articulated device, such as an ultrasonic probe. This facilitates the accurate use of these instruments.

Among other things, the distal tip and / or working end of the endoscope can be fixed and / or stabilized (and thus inserted through the working channel of such an endoscope, a grasper, a cutter. Or it is very important to provide new equipment (which can also fix and / or stabilize the distal tip and / or work end of other instruments, such as anatomical instruments, ablation tools, ultrasonic probes, etc.) It is advantageous to.

Also, the distal tip and / or work end of an instrument (such as a grasper, cutter or anatomical instrument, ablation tool, ultrasonic probe) that can be advanced to the surgical site by means other than through the working channel of the endoscope. It is very advantageous to provide a novel device that can be fixed and / or stabilized.

It is possible to straighten the curve to "iron out" the folds on the surface of the lumen, creating a substantially stationary or stable side wall of the body cavity and / or body cavity. Is also very advantageous, which allows for more accurate visual examination (including visualization of areas initially hidden from or outside the field of view) and / or therapeutic intervention. ..

It is an object of the present invention to better present side wall tissue for examination and / or treatment during an endoscopic procedure, including visualization of areas initially hidden from or outside the field of view. Includes the provision and use of new devices for manipulating the body lumen and / or the side walls of the body cavity.

The present invention also refers to an instrument (eg, an endoscope, a grasper, a cutter or anatomical instrument, a cauterizing tool) that is inserted into the body lumen and / or the body cavity relative to the body cavity and / or the side wall of the body cavity. And the provision and use of new devices capable of fixing and / or stabilizing the distal tip and / or working end of articulated and / or non-articulated devices such as ultrasound probes. Including, thereby facilitating the correct use of these instruments.

Among other things, the present invention can fix and / or stabilize the distal tip and / or working end of the endoscope (and thus be inserted through the working channel of such an endoscope. Providing new equipment (which can also fix and / or stabilize the distal tip and / or working edge of other instruments, such as graspers, cutters or anatomical instruments, ablation tools, ultrasonic probes, etc.) And use.

The present invention also describes the distal tip and / of instruments (graspers, cutters or anatomical instruments, cauterizing tools, ultrasonic probes, etc.) that can be advanced to the surgical site by means other than through the working channel of the endoscope. Or include the provision and use of new equipment capable of fixing and / or stabilizing the working end.

It is also possible to straighten the curved portion to "wrinkle" the folds to create a substantially stationary or stable side wall of the body cavity and / or body cavity. Includes the provision and use of new equipment, which enables more accurate visual examination (including visualization of areas initially hidden from or outside the field of view) and / or therapeutic intervention. ..

A device is provided in a preferred embodiment of the present invention, wherein the device is:
With a sleeve adapted to slide over the outer part of the endoscope;
With the proximal balloon attached to the sleeve;
With an expansion / contraction tube carried by the sleeve and fluid communication inside the proximal balloon;
With a push tube that is slidably installed on the sleeve;
A distal balloon fixed to the distal end of the push tube, wherein the inside of the distal balloon is fluidly communicated with the push tube and the distal balloon is in a contracted and inflated state. In addition, when the distal balloon is in its contracted state, the axial opening extends through it and the axial opening is sized to receive the endoscope inside. It comprises a distal balloon in which the axial opening is closed when the distal balloon is in its inflated state.

In another preferred embodiment of the invention, a method for performing a procedure within a body lumen and / or a body cavity is provided, the method described above:
To provide a device, this device is:
With a sleeve adapted to slide over the outer part of the endoscope;
With the proximal balloon attached to the sleeve;
With an expansion / contraction tube carried by the sleeve and fluid communication inside the proximal balloon;
With a push tube that is slidably installed on the sleeve;
A distal balloon fixed to the distal end of the push tube, wherein the inside of the distal balloon is fluidly communicated with the push tube and the distal balloon is in a contracted and inflated state. In addition, when the distal balloon is in its contracted state, the axial opening extends through it and the axial opening is sized to receive the endoscope inside. With a distal balloon, the axial opening is closed when the distal balloon is in its inflated state;
Positioning the device within the body lumen and / or the body cavity;
Inflating the proximal balloon;
To advance the push tube distally;
Inflating the distal balloon;
Including performing the procedure.

In another preferred embodiment of the invention, the device is provided, which is:
A sleeve adapted to slide over the outer portion of the endoscope, the sleeve being integrally formed with a passage formed integrally with the sleeve and the sleeve for receiving an instrument. With a sleeve, with a lumen;
With the proximal balloon attached to the sleeve;
With an expansion / contraction tube carried by the sleeve and fluid communication inside the proximal balloon;
With a push tube slidably installed in the passage of the sleeve;
It is a distal balloon fixed to the distal end of the push tube, and includes a distal balloon in which the inside of the distal balloon is fluid-communicated with the push tube.

In another preferred embodiment of the invention, a method for performing a procedure within a body lumen and / or a body cavity is provided, the method described above:
To provide a device, this device is:
A sleeve adapted to slide over the outer portion of the endoscope, the sleeve being integrally formed with a passage formed integrally with the sleeve and the sleeve for receiving an instrument. With a sleeve, with a lumen;
With the proximal balloon attached to the sleeve;
With an expansion / contraction tube carried by the sleeve and fluid communication inside the proximal balloon;
With a push tube slidably installed in the passage of the sleeve;
A distal balloon anchored to the distal end of the push tube, comprising a distal balloon through which the interior of the distal balloon is fluidly communicated with the push tube;
Positioning the device within the body lumen and / or the body cavity;
Inflating the proximal balloon;
To advance the push tube distally;
Inflating the distal balloon;
Including performing the procedure.

In another preferred embodiment of the invention, the device is provided, which is:
Fitted to slide over the outer portion of the endoscope to substantially cover the endoscope from the point adjacent to the distal end of the endoscope to the point adjacent to the handle of the endoscope With a sleeve;
With the proximal balloon attached to the sleeve;
With an expansion / contraction tube carried by the sleeve and fluid communication inside the proximal balloon;
With a push tube that is slidably installed on the sleeve;
It is a distal balloon fixed to the distal end of the push tube, and includes a distal balloon in which the inside of the distal balloon is fluid-communicated with the push tube.

In another preferred embodiment of the invention, a method for performing a procedure within a body lumen and / or a body cavity is provided, the method described above:
To provide a device, this device is:
Fitted to slide over the outer portion of the endoscope to substantially cover the endoscope from the point adjacent to the distal end of the endoscope to the point adjacent to the handle of the endoscope With a sleeve;
With the proximal balloon attached to the sleeve;
With an expansion / contraction tube carried by the sleeve and fluid communication inside the proximal balloon;
With a push tube that is slidably installed on the sleeve;
A distal balloon anchored to the distal end of the push tube, comprising a distal balloon through which the interior of the distal balloon is fluidly communicated with the push tube;
Positioning the device within the body lumen and / or the body cavity;
Inflating the proximal balloon;
To advance the push tube distally;
Inflating the distal balloon;
Including performing the procedure.

In another preferred embodiment of the invention, the device is provided, which is:
With a sleeve adapted to slide over the outer part of the endoscope;
With the proximal balloon attached to the sleeve;
With an expansion / contraction tube carried by the sleeve and fluid communication inside the proximal balloon;
With a pair of push tubes that are slidably installed on the sleeve;
It is a distal balloon fixed to the distal end of the pair of push tubes, and includes a distal balloon in which the inside of the distal balloon is fluidly communicated with the pair of push tubes.

In another preferred embodiment of the invention, a method for performing a procedure within a body lumen and / or a body cavity is provided, the method described above:
To provide a device, this device is:
With a sleeve adapted to slide over the outer part of the endoscope;
With the proximal balloon attached to the sleeve;
With an expansion / contraction tube carried by the sleeve and fluid communication inside the proximal balloon;
With a pair of push tubes that are slidably installed on the sleeve;
A distal balloon fixed to the distal end of the pair of push tubes, comprising a distal balloon in which the inside of the distal balloon communicates fluidly with the pair of push tubes. ;
Positioning the device within the body lumen and / or the body cavity;
Inflating the proximal balloon;
To advance the pair of push tubes distally;
Inflating the distal balloon;
Including performing the procedure.

In another preferred embodiment of the invention, an endoscopic tissue retraction system is provided, which is an endoscopic tissue retraction system:
With elements that are configured to be movably installed in the endoscope;
It comprises an element and a connector configured to be anchored to the tissue to be retracted.

In another preferred embodiment of the invention, a method of endoscopically retracting tissue is provided, which method is:
Placing the endoscope and the elements that are movably placed on the endoscope adjacent to the tissue to be retracted;
To secure the connector to the element and the tissue to be retracted;
Includes using a connector to urge the tissue away from the endoscope.

In another preferred embodiment of the invention, a device for endoscopic tissue recovery is provided, which device is:
With a balloon configured to be movablely placed on the endoscope;
It has an eyelet formed on the balloon.

In another preferred embodiment of the invention, a method of endoscopically retracting tissue is provided, which method is:
To place the endoscope and the element movably placed on the endoscope adjacent to the tissue to be retracted, that the connector is fixed to the element;
Sticking the connector to the tissue to be retracted;
Includes using a connector to urge the tissue away from the endoscope.

In another preferred embodiment of the invention, a method of endoscopically retracting tissue is provided, which method is:
Placing the endoscope and the elements that are movably placed on the endoscope adjacent to the tissue to be retracted;
Sticking the tissue to be retracted to the element;
Includes urging tissue away from the endoscope by moving the element.

In another preferred embodiment of the invention, a device for endoscopic tissue retraction, which is:
A balloon configured to be movably placed on the endoscope, the balloon can be in contracted and inflated states, and if the balloon is in that contracted state, there is an axial opening there. If it extends through and the balloon is in its inflated state, the axial opening is closed, with the balloon;
Along with the perimeter of the balloon, it is provided with a flap that is placed within the axial opening of the balloon to form a concave pouch to receive the exfoliated tissue.

In another preferred embodiment of the invention, a method for recovering endoscopic tissue, which method is:
By placing the balloon assembly distal to the tissue to be recovered, the balloon assembly is movably placed in the endoscope and the balloon assembly is (i) in a contracted and inflated state. A balloon that can be, and if the balloon is in its contracted state, an axial opening extends through it, and if the balloon is in its inflated state, the axial opening is closed, the balloon, and (Ii) To include, in conjunction with the perimeter of the balloon, a flap placed within the axial opening of the balloon to form a concave pouch to receive the tissue to be recovered;
Placing the tissue to be recovered in a concave pouch;
Includes retracting the balloon assembly proximally to recover the tissue received within the concave pouch.

In another preferred embodiment of the invention, an additional system for endoscopically retracting tissue is provided.

In another preferred embodiment of the invention, an additional method for endoscopically retracting tissue is provided.

A device for endoscopically retracting tissue is provided in a preferred embodiment of the present invention.
With a sleeve adapted to slide over the outer part of the endoscope;
With a balloon that is movably installed on the sleeve;
With at least one connector extending from the balloon, configured to adhere to the tissue to be retracted,
The balloon is configured to be moved relative to the sleeve for the purpose of retracting tissue.

In another preferred embodiment of the invention, a method for endoscopically retracting tissue is provided, which method is:
To provide a device for endoscopically retracting tissue, this device is:
With a sleeve adapted to slide over the outer part of the endoscope;
With a balloon that is movably installed on the sleeve;
With at least one connector extending from the balloon, configured to be anchored to the tissue to be retracted;
Positioning the endoscope placed in the sleeve so that it is adjacent to the tissue to be retracted;
Sticking at least one connector to the balloon and the tissue to be retracted;
Includes retracting tissue away from the endoscope by moving the balloon away from the endoscope.

In another preferred embodiment of the present invention, a device for endoscopically retracting tissue is provided, which:
With a sleeve adapted to slide over the outer part of the endoscope;
With a tensioning tool that extends through the sleeve and is configured to adhere to the tissue to be retracted;
To be equipped.

In another preferred embodiment of the invention, a method for endoscopically retracting tissue is provided, which method is:
To provide a device for endoscopically retracting tissue, this device is:
With a sleeve adapted to slide over the outer part of the endoscope;
With a tensioning tool that extends through the sleeve, configured to adhere to the tissue to be retracted;
To be equipped with;
Positioning the endoscope placed in the sleeve so that it is adjacent to the tissue to be retracted;
Connecting a tensioning tool to the tissue to be retracted;
Includes retracting tissue by moving the tensioning tool relative to the endoscope.

In another preferred embodiment of the present invention, a device for endoscopically retracting tissue is provided, which:
With a sleeve adapted to slide over the outer part of the endoscope;
A pair of push tubes that are slidably installed on the sleeve, with a pair of hollow push tubes that are connected to each other at their ends using a bridge;
With at least one connector extending from the bridge, configured to be anchored to the tissue to be retracted,
A pair of push tubes are configured to be moved relative to the sleeve for the purpose of retracting tissue.

In another preferred embodiment of the invention, a method for endoscopically retracting tissue is provided, which method is:
To provide a device for endoscopically retracting tissue, this device is:
With a sleeve adapted to slide over the outer part of the endoscope;
A pair of push tubes that are slidably installed on the sleeve, with the pair of push tubes connected to each other at their ends using a bridge;
With at least one connector extending from the bridge, configured to be anchored to the tissue to be retracted;
Positioning the endoscope placed in the sleeve so that it is adjacent to the tissue to be retracted;
At least sticking the connector to a pair of push tubes and the tissue to be retracted;
Includes retracting tissue away from the endoscope by moving a pair of push tubes relative to the endoscope.

The following detailed description of preferred embodiments of the invention will more fully disclose or clarify these and other purposes and features of the invention, as are these preferred embodiments of the invention. The reference numerals of are considered with the accompanying drawings showing similar parts.

FIG. 6 is a schematic showing a novel device formed in accordance with the present invention, wherein the novel device is, among other things, a sleeve for being placed over the end of the endoscope and a rear mounted on the sleeve. It comprises a balloon, a pair of push tubes slidably installed on the sleeve, an anterior balloon installed at the distal end of the push tube, and a push tube handle installed at the proximal end of the push tube. It is a schematic diagram which shows various arrangements of anterior balloons with respect to a posterior balloon. It is a schematic diagram which shows various arrangements of anterior balloons with respect to a posterior balloon. It is a schematic diagram which shows various arrangements of anterior balloons with respect to a posterior balloon. FIG. 5 is a schematic showing further details of the distal end of the device shown in FIG. It is sectional drawing which follows line 6-6 of FIG. FIG. 6 is a schematic showing further details of the anterior balloon. FIG. 6 is a schematic showing further details of the anterior balloon. It is the schematic which shows the push tube handle. It is the schematic which shows the structural detail of the anterior balloon. It is the schematic which shows the structural detail of the anterior balloon. It is a schematic diagram which shows one form of the expansion mechanism provided according to this invention. It is a schematic diagram which shows another form of the expansion mechanism provided according to this invention. It is a schematic diagram which shows another form of the expansion mechanism provided according to this invention. It is a schematic diagram which shows another form of the expansion mechanism provided according to this invention. FIG. 5 is a schematic showing a relief valve that can be used to ensure that pressure in the anterior and / or posterior balloon does not exceed a predetermined level. FIG. 5 is a schematic diagram showing a retreat system that can be used to remove slack in the flexible tube of the device shown in FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the preferable method using the apparatus of FIG. It is the schematic which shows the alternative structure of the push tube and the push tube handle of this invention. FIG. 6 is a schematic showing another form of the sleeve, the sleeve comprising an additional lumen for receiving the instrument. FIG. 6 is a schematic showing how the instrument can be advanced through the additional lumen of the sleeve. FIG. 6 is a schematic showing how the instrument can be advanced through the additional lumen of the sleeve. FIG. 6 is a schematic showing how the instrument can be advanced through the additional lumen of the sleeve. FIG. 6 is a schematic showing how the instrument can be advanced through the additional lumen of the sleeve. FIG. 6 is a schematic showing an instrument guide tube that can be placed in the additional lumen of the sleeve, where the instrument can be advanced to pass through the instrument guide tube. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. It is a schematic diagram which shows the endoscopic tissue retraction system formed according to this invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. It is a schematic diagram showing a suitable technique using an endoscopic tissue retraction system formed according to the present invention. It is a schematic diagram showing a suitable technique using an endoscopic tissue retraction system formed according to the present invention. It is a schematic diagram showing a suitable technique using an endoscopic tissue retraction system formed according to the present invention. It is a schematic diagram showing a suitable technique using an endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention. FIG. 6 is a schematic showing another endoscopic tissue retraction system formed according to the present invention.

It is an object of the present invention to better present side wall tissue for examination and / or treatment during an endoscopic procedure, including visualization of areas initially hidden from or outside the field of view. Includes the provision and use of new devices for manipulating the body lumen and / or the side walls of the body cavity.

(The term "endoscopic procedure" as used herein is intended for visual inspection, biopsy and / or treatment of tissue, including removing lesions and / or removing tissue. Virtually any minimally invasive or limited access to the body lumen and / or the interior of the body cavity by using a lumen endoscope or transluminally or otherwise. Is intended to mean access procedures for diagnosis and / or therapy and / or surgery.)

The present invention also refers to an instrument (eg, an endoscope, a grasper, a cutter or anatomical instrument, a cauterizing tool) that is inserted into the body lumen and / or the body cavity relative to the body cavity and / or the side wall of the body cavity. And the provision and use of new devices capable of fixing and / or stabilizing the distal tip and / or working end of articulated and / or non-articulated devices such as ultrasound probes. Including, thereby facilitating the correct use of these instruments.

Among other things, the present invention can fix and / or stabilize the distal tip and / or working end of the endoscope (and thus be inserted through the working channel of such an endoscope. Providing new equipment (which can also fix and / or stabilize the distal tip and / or working edge of other instruments, such as graspers, cutters or anatomical instruments, ablation tools, ultrasonic probes, etc.) And use.

The present invention also describes the distal tip and / of instruments (graspers, cutters or anatomical instruments, cauterizing tools, ultrasonic probes, etc.) that can be advanced to the surgical site by means other than through the working channel of the endoscope. Or include the provision and use of new equipment capable of fixing and / or stabilizing the working end.

It is also possible to straighten the curved portion to "wrinkle" the folds to create a substantially stationary or stable side wall of the body cavity and / or body cavity. It involves the provision and use of new equipment, which allows for more accurate visual examination (including visualization of areas initially hidden from or outside the field of view) and / or therapeutic intervention.

(New device)
According to the present invention, and also with reference to FIG. 1, the side wall tissue is better for examination and / or treatment during an endoscopic procedure using an endoscope 10 (eg, a concatenated endoscope). For the purpose of presenting to (including visualization of areas initially hidden from or outside the field of view) and / or the distal end of the endoscope 10 and / or other instruments (eg, figure). Manipulate the body lumen and / or the side wall of the body cavity to stabilize the distal tip and / or working edge of a grasper, cutter or anatomical instrument, ablation tool, ultrasonic probe, etc. (not shown in 1). , Stabilization, straightening, inflating, and / or flattening, etc.) are shown.

More specifically, the device 5 is generally attached to the sleeve 15 which is adapted to slide on the outer portion of the shaft of the endoscope 10 and to the sleeve 15 near the distal end of the sleeve. Proximal (or "rear") balloon 20 and (the terms "proximal" and "rear" are used interchangeably below) on the sleeve 15 at the proximal end of the sleeve. It includes a base 25 to be fixed. A pair of push tubes 30 slidably installed on the sleeve 15 and a distal side (or "forward") of the device 5 anchored to the distal end of the push tubes 30, as discussed later herein. ”) The balloon 35 and (the terms“ distal ”and“ anterior ”are used interchangeably herein below) are further provided, and as a result, between the posterior balloon 20 and the anterior balloon 35. The spacing is by moving the push tube 30 relative to the sleeve 15 by a physician (or other operator or user) (eg, by simultaneously advancing the two push tubes at the push tube handle 37 (below). )), Can be adjusted. See FIGS. 1 and 2-4. A coupled inflatable mechanism 40 (FIG. 5) to allow the device 5 to selectively inflate / contract one or both of the posterior balloon 20 and the anterior balloon 35 by a physician (or other operator or user). 1) is further provided.

Next, referring to FIGS. 1 to 6, the sleeve 15 is generally slid on the outer portion of the shaft of the endoscope 10 so as to form a tight fit with the shaft of the endoscope 10 (eg, endoscopy). It features an elongated thin-walled tube configured to (opposite from the distal tip of the mirror), where the sleeve is placed over the endoscope (preferably with the scope "dry"). Sometimes easily slides in the opposite direction on the endoscope but has sufficient residual friction with the outer surface of the endoscope (held by the hand of a doctor or other operator or user) As such (when), the sleeve is sized and configured so that the sleeve torques the endoscope during use (ie, swivels by rotation) and pushes / pulls the endoscope (eg, of the patient's). It will stay in place to allow (inside the colon). In a preferred embodiment of the invention, the sleeve 15 can move around the endoscope 10 to some extent in a circumferential manner (and is firmly held in the hands of a doctor or other operator or user). Can rotate with the endoscope shaft). However, the sleeve 15 can nominally move only in the axial direction with respect to the endoscope 10. The sleeve 15 is sized (along with the base 25) so that it substantially covers the endoscope shaft when its distal end is substantially aligned with the distal end of the endoscope 10. Will be done. In either case, the sleeve 15 will extend out of the patient's body when the sleeve 15 is placed on the endoscope 10 and the endoscope 10 is inserted into the patient. As such, it is sized. In a preferred embodiment of the invention, the device 5 is provided according to the particular endoscope with which it is intended to be used, where the device 5 has a base 25 engaged with the handle of the endoscope. The distal end of the sleeve 15 when it is being placed so that it is located approximately at the distal end of the endoscope, i.e., substantially aligned with or within the distal end of the endoscope. It is sized so that it is aligned slightly proximal to the distal end of the endoscope.

If desired, the distal end of the sleeve 15 can be equipped with a radially medially extending stop (not shown) that securely engages the distal end surface of the endoscope 10. This prevents the distal end of the sleeve 15 from moving proximally beyond the distal end surface of the endoscope 10. Such an inwardly extending stop portion of the sleeve 15 with respect to the endoscope 10 when torqued (ie, swiveled by rotation) the endoscope when it is in the colon. It can assist in preventing a "torque slip" and / or a "thrust slip" of the sleeve 15 with respect to the endoscope 10 when pushing the endoscope forward while in the colon.

The sleeve 15 preferably has a smooth outer surface so as to be non-traumatic to the tissue and is preferably made of a highly flexible material so that the sleeve is inner during use. Does not prevent the endoscope from bending. In a preferred embodiment of the invention, the sleeve 15 comprises polyurethane, polyethylene, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), etc., and preferably sleeves marking the distance on the endoscope 10. Transparent (or at least translucent) to allow visualization through 15. Also, in a preferred embodiment of the invention, the sleeve 15 preferably has a nominal hoop strength so that the physician (or other operator or user) can use the endoscope 10 through the sleeve 15. It can be grasped, thereby applying torque to, for example, an endoscope. If desired, the sleeve 15 may have a lubricating coating (eg, a liquid such as a synthetic oil of perfluoropolyether, a powder, etc.) on a portion or all of its inner and / or outer surface. It can, thereby facilitating the placement of the sleeve over the endoscope and / or the movement of the device 5 through the body and / or body cavities. Alternatively, the sleeve 15 may be made of a material that is itself lubricating, such as polytetrafluoroethylene (PTFE). It should be recognized that the inner surface of the sleeve 15 can have features (eg, protrusions) to prevent the sleeve from rotating with respect to the endoscope during use.

If desired, a vacuum is "pulled" between the sleeve 15 and the endoscope 10, thereby anchoring the sleeve 15 to the endoscope 10 and minimizing the profile of the sleeve 15. For example, but not limited to, a vacuum can be introduced at the proximal end of the sleeve 15 (ie, at the base 25), or a vacuum can be introduced at an intermediate position in the sleeve 15. As a further example, but not limited to, fluid (eg, air, or, for example, air) in the space between the sleeve 15 and the endoscope 10 at, for example, at the proximal end of the sleeve 15 (ie, at the base 25) or in the middle of the sleeve 15. , Liquid lubricant), it should be recognized that the removal of the sleeve 15 from the endoscope 10 (eg, at the end of the procedure) can be facilitated.

Further referring to FIGS. 1-6, the posterior balloon 20 is located near the distal end of the sleeve but in the immediate vicinity of the proximal side of the endoscopic articulated junction away from the distal end of the sleeve. , Fixed to the sleeve 15. The rear balloon 20 is placed concentrically about the sleeve 15, and therefore also centered around the endoscope 10 that is placed inside the sleeve 15. Therefore, the rear balloon 20 has a roughly donut shape. The rear balloon 20 can be selectively inflated / contracted by the proximal expansion / contraction tube 45, with the distal end of the proximal expansion / contraction tube 45 fluid communicating within the rear balloon 20 and also. The proximal end of the proximal expansion / contraction tube 45 is fluidized to a fitting 46 installed at the base 25. The fitting 46 is configured to be connected to the coupled expansion mechanism 40 mentioned above. The fitting 46 is preferably a luer actuating valve, which allows the expansion mechanism 40 to be removed from the fitting 46 without losing pressure in the rear balloon 20. The expansion / contraction tube 45 may be anchored to the outer surface of the sleeve 15, or more preferably, the expansion / contraction tube 45 may be contained within a lumen 47 formed within the sleeve 15.

Preferably, the rear balloon 20 is located a short distance posterior to the distal end of the sleeve 15, that is, approximately the same distance as the length of the articulated portion of the maneuverable endoscope 10. As a result, when the maneuverable endoscope is placed within the sleeve 15, the articulated portion of the maneuverable endoscope is placed distal to the rear balloon 20. This configuration allows the flexible portion of the maneuverable endoscope to be articulated even when the posterior balloon 20 is inflated within the anatomy, as discussed in more detail later herein. , Thereby stabilizing the adjacent non-connecting parts of the endoscope with respect to the biological structure. Thus, the posterior balloon 20 provides a robust platform for maintaining the endoscope 10 in a stable position within the body lumen or body cavity when inflated, where the endoscope 10 is located in the body lumen or body cavity. It is placed in the center. As a result, the endoscope 10 can improve the visualization of the biological structure. Further, through the internal lumen of the endoscope 10 (sometimes referred to as a "working channel"), the inflated posterior balloon 20 keeps the endoscope 10 firmly within the body lumen or body cavity. The instruments that are advanced will also be provided with a solid platform for supporting them in or within the body lumen.

When the posterior balloon 20 is properly inflated, the posterior balloon is non-traumatically engaged with the side wall of the body lumen where the device 5 is located to create a sealing relationship with the side wall of the body lumen. Can be formed.

In a preferred embodiment of the invention, the rear balloon 20 is formed from polyurethane.

The base 25 is secured to the proximal end of the sleeve 15. The base 25 is engaged with the endoscope 10 to assist in anchoring the entire assembly (ie, device 5) to the endoscope 10. The base 25 preferably comprises a substantially rigid or semi-rigid structure that can be grasped by a physician (or other operator or user) and pulled proximally. Thereby, the doctor (or other operator or user) can pull the sleeve 15 over the distal end of the endoscope 10 and return it to the proximal side along the length direction of the endoscope 10. This allows the sleeve 15 to be placed on the outer surface of the endoscope shaft. In a preferred embodiment of the invention, the base 25 is pulled proximally along the endoscope until the base 25 is seated in contact with the handle of the endoscope, thereby proximal to the base 25. Further lateral movement is impeded (and thus impeded further lateral movement of the sleeve 15). In a preferred embodiment of the invention, the base 25 forms a closed engagement with the endoscope 10.

The push tube 30 is slidably mounted on the sleeve 15 so that the distal end of the push tube can be stretched and / or retracted relative to the sleeve 15 (eg, pushed through the push tube handle 37). By advancing or retracting the tube (see below), and thus can be stretched and / or retracted relative to the distal end of the endoscope 10 placed within the sleeve 15. Preferably, the push tube 30 is slidably disposed within the support tube 50, which is secured to the outer surface of the sleeve 15, or more preferably, within the lumen 52 formed within the sleeve 15. include. The support tube 50 is preferably used to minimize resistance to movement of the push tube 30 relative to the support tube 50 (and thus to minimize resistance to movement of the push tube 30 relative to the sleeve 15). ), Made of low friction material (eg, polytetrafluoroethylene, also known as "PTFE"). In this regard, minimizing resistance to movement of the push tube 30 relative to the support tube 50 improves tactile feedback to the user when using the push tube 30 to operate the anterior balloon 35. I want to be recognized. In one embodiment of the invention, the support tube 50 is flexible (allowing the joint portion of the endoscope 10 and particularly the maneuverable endoscope 10 to be curved as needed during the procedure). The support tube 50 also provides some column strength. Therefore, when the support tube 50 is installed in the lumen 52 formed in the sleeve 15, the assembly of the sleeve 15 and the support tube 50 is flexible but has a certain degree of column strength (as opposed to). Therefore, the sleeve 15 alone has flexibility, but has substantially no column strength). If the push tube 30 is contained within a lumen 52 formed within the sleeve 15, and if the support tube 50 is not located between the push tube 30 and the lumen 52, then the lumen 52 is preferably pushed. It is lubricated to minimize friction between the tube 30 and the lumen 52.

The proximal end of the push tube 30 is connected to the push tube handle 37. As a result of this configuration, pushing the push tube handle 37 distally causes the distal end of the push tube 30 to move distally (with equal variation) relative to the sleeve 15. , Move the anterior balloon 35 to the distal side with respect to the rear balloon 20), and by pulling the push tube handle 37 to the proximal side, the distal end of the push tube 30 is proximal to the sleeve 15. (Thus moving the anterior balloon 35 proximally with respect to the posterior balloon 20). Note that moving the push tube 30 to the distal or proximal side with equal variation keeps the distal ends of the push tube parallel to each other. Clamps 53 (FIGS. 12 and 15) are provided at the base 25 to hold the push tube 30 in a selected arrangement relative to the base 25 (and thus a selected arrangement relative to the sleeve 15). ..

The push tube 30 preferably has good column strength, such as, for example, a thermoplastic polyethylene resin such as Isoblast ™ (available from Lubrizol, Wickliffe, Ohio), polyethylene, polypropylene, nylon, and the like. Formed from a relatively flexible material that provides. Recognize that the push tube 30 can contain a single material or multiple materials, and that the stiffness of the push tube 30 may vary along their length. For example, but not limited to, the most distal portion of the push tube 30 can be made of the same material as the rest of the push tube, but with a lower modulus to have higher flexibility than the rest of the push tube. You can do it. Alternatively, the most distal portion of the push tube 30 can include another flexible material with higher elasticity. For example, but not limited to, the most distal portion of the push tube 30 can include the Nitinol. As a further example, but not limited to, a stainless steel coil in which the most distal portion of the push tube 30 is covered with an outer jacket of polytetrafluoroethylene (PTFE) can be provided, in which the most distal jacket. / The more proximal tubules integrally provide a sealed lumen for inflating / contracting the anterior balloon 35. By forming the push tube 30 such that it has a distal end that is more flexible than the rest of the push tube, the push tube 30 and the anterior balloon 35 are integrally device, as will be further discussed later. It can function as a lead (with a soft, non-traumatic tip) for the 5 and the endoscope 10.

In a preferred embodiment of the invention, the push tube 30 is configured to maintain a parallel arrangement when in a non-urging state, i.e. when no force is applied to the push tube 30. This is true regardless of the inflated or deflated state of the anterior balloon 35.

The most distal portion of the push tube 30 can be configured to bend inward or outward if desired. By using such a configuration, the distal end of the push tube 30 is held stationary (eg, by an inflated anterior balloon, as discussed later herein), which is sufficient in the distal direction. A force is applied to the push tube 30, which allows the intermediate portion of the push tube 30 (ie, the portion between the inflated anterior balloon 35 and the sleeve 15) to bend outward or flex outward. Pushes the side wall of the body cavity where the device 5 is located inward outwards, thereby causing the body cavity and / or the side wall of the body cavity to "" in the space between the posterior balloon 20 and the anterior balloon 35. The "tent" effect is obtained. This "tent" effect provides visibility and / or visibility within the distal region of the endoscope 10 by pushing outward the body lumen and / or the side wall of the body cavity where the device 5 is located. Tissue stability can be significantly improved.

In addition, by forming the push tube 30 from a flexible material, the push tube interferes with the visualization of the patient's biological structure and / or a diagnostic tool or treatment to the space between the anterior and posterior balloons. Manually adjusting the position of the push tube 30 during use (eg, by using a separate tool to torque the device, with the aim of preventing the push tube from interfering with the introduction of the tool. Please be aware that by giving, etc.) is possible. Use a separate tool or instrument, for example, if the device 5 is placed within the anatomy in such a way that the push tube 30 blocks visual or physical access to the target area of the anatomy. The flexible push tube 30 is moved out of the way by, or by rotating the device in a torque-giving motion that moves the flexible push tube 30 out of the way. obtain. As a further example, but not limited to, circular endoscopy during concatenation by configuring the push tube 30 to be circular, flexible, and have a diameter significantly smaller than the circumference of the endoscope 10. Moving the mirror allows the push tube to be simply pushed out of the way, providing an unobstructed visual path to the tissue of interest.

Also, if desired, an indicator containing a distance marker (not shown), such as a colored indicator or an X-ray opaque indicator, may be attached to the push tube 30, resulting in an endoscope. A doctor (or other operator or user) observing the surgical site via 10 or by X-ray guidance (eg, X-ray fluoroscopy) refers to the side walls of the body cavity and / or other body cavity. It should be recognized that the relative placement of the push tube 30 at the surgical site can be confirmed in both the longitudinal and / or circumferential directions.

As discussed in more detail below herein, the push tubes 30 are hollow, their distal ends through which fluid is communicated within the anterior balloons 35 (FIGS. 1-5, 7 and 8), and They have their internal lumens that allow fluid communication to the fittings 56 installed at the base 25. The fitting 56 is configured to be connected to the coupled inflating mechanism 40 mentioned above, so that the anterior balloon 35 is selectively inflated / contracted with air or other fluid (including liquid). You will get it. The fitting 56 is preferably a luer actuating valve, which allows the expansion mechanism 40 to be removed from the fitting 56 without losing pressure in the front balloon 35.

More specifically, in a preferred embodiment of the invention, and with reference to FIG. 8A, the push tube handle 37 comprises a hollow interior 57. The push tube 30 is installed in the push tube handle 37, so that the push tube 30 moves in conjunction with the push tube handle 37, and further, the hollow inside of the push tube 30 is hollow in the push tube handle 37. The fluid will be communicated to the inside 57. The push tube handle 37 further comprises a fitting 58 for fluid communication to the hollow interior 57 of the push tube handle 37. A flexible tube 59 is connected to the fitting 58 such that it has an internal chamber (not shown) within the base 25, wherein this internal chamber within the base 25 is attached to the fitting 56 mentioned above. Fluid communication. As a result of this configuration, if the push tube handle 37 is moved distally, the anterior balloon 35 will be moved distally, and if the push tube handle 37 is moved proximally. , The anterior balloon 35 will be moved to the proximal side. Further, when a positive fluid pressure is applied to the fitting 56 in the base 25, a positive fluid pressure is applied to the internal lumen of the anterior balloon 35, thereby inflating the anterior balloon 35 and also. When a negative fluid pressure is applied to the fitting 56 in the base 25, a negative fluid pressure is applied to the internal lumen of the anterior balloon 35, thereby causing the anterior balloon 35 to contract.

Please be aware that there are many benefits to having a dual push tube. For example, by providing a dual push tube, a force symmetrical to the anterior balloon 35 as the anterior balloon is advanced distally into the body lumen, as discussed later herein. Will be added. Further, by providing the dual push tube 30, a push tube is adopted to straighten the biological structure in the region near the distal end of the endoscope 10, as will be discussed later in the present specification. Equal outward force is provided to adjacent biostructures, thereby improving visualization and / or access to biostructures. In addition, the dual push tube ensures that the anterior balloon 35 remains centered on the endoscope 10, as will be discussed later herein. It becomes easy to separate the anterior balloon 35 from the endoscope 10 and reassemble the anterior balloon 35 onto the endoscope 10. In addition, the provision of the dual push tube 30 assists in ensuring that the anterior balloon 35 is stabilized relative to the tip of the endoscope, thereby minimizing the rotational movement of the anterior balloon during expansion. In addition, the hollow dual push tube will provide an overlapping air transfer system for inflating or deflating the anterior balloon 35.

The anterior balloon 35 is anchored to the distal end of the push tube 30, thereby moving the push tube 30 relative to the sleeve 15, ie, moving the push tube handle 37 relative to the sleeve 15 to the rear. The spacing between the balloon 20 and the anterior balloon 35 can be adjusted. In addition, the hollow push tube 30 provides a conduit between the interior of the anterior balloon 35 and the attachment 56, thereby allowing the anterior balloon 35 to be selectively inflated / contracted via the attachment 56. ..

Importantly, the anterior balloon 35 is configured to result in: (i) contracted (or partially contracted) and its "backward" relative to the sleeve 15. When in position (FIG. 2), the anterior balloon 35 provides an axial opening 63 (FIGS. 7, 8 and 10) sufficient to accommodate the sleeve 15 and the shaft of the endoscope 10 therein. (Ii) The anterior balloon 35 is in its "extended" position with respect to the sleeve 15 and is properly inflated. If so (FIG. 4), the axial opening 63 is closed (and preferably completely closed). At the same time, when properly inflated, the anterior balloon is non-traumatically engaged with the body lumen and / or the side wall of the body cavity where the device 5 is located in the body lumen and / or. A closed relationship can be formed with the side wall of the body cavity. Thus, when the anterior balloon 35 is properly inflated, the anterior balloon has a closed relationship with the body lumen and / or the side wall of the body cavity where the axial opening 63 is closed and the device 5 is located therein. By forming, the body lumen and / or the body cavity can be effectively sealed on the distal side of the anterior balloon 35. By doing so, there are two cases where the push tube 30 is advanced distally to separate the anterior balloon 35 from the posterior balloon 20 and when the anterior balloon 35 and the posterior balloon 20 are properly inflated. The balloon will form a closed zone between them (sometimes referred to herein as the "treatment zone").

When the anterior balloon 35 is reconstructed from its contracted state to its inflated state, the anterior balloon 35 inflates radially inward (thus closing the axial opening 63) and further radially outward (and thereby peripherals). It will be recognized (engaged with the tissue).

Thus, the anterior balloon 35 has a "torus" shape when contracted (which allows it to sit on the distal end of the endoscope) and a substantially "solid" shape when inflated. (It allows the body lumen or body cavity to be closed), you will find.

For this purpose, then with reference to FIGS. 9 and 10, the anterior balloon 35 is preferably a "key shape" having a body 67 with a proximal opening 69 and a distal opening 71 and a lobe 74. Manufactured as a single configuration comprising a proximal extension 73 having a cross section and a distal extension 76 having a circular cross section. It should be noted that the lobes 74 are placed on the proximal extension 73 so that they have a configuration that fits the configuration of the push tubes 30 (ie, the two push tubes 30 with the devices 5 radially opposite to each other. If the proximal extension 73 is provided with two lobes 74 that are radially opposite to each other; the device 5 has three push tubes 30 that are uniform in the circumferential direction around the boundary of the sleeve 15. When the proximal side extension portion 73 is provided with three lobes 74 which are uniform in the circumferential direction about the boundary of the proximal side extension portion 73, and the device 5 includes one push tube 30. (The proximal extension 73 and the lobe 74 will collectively comprise one lobe 74, etc.) (In the present invention, the proximal extension 73 and the lobe 74 are collectively referred to as having a "key-shaped" cross section. May be)). During assembly, the push tube 30 is seated in the lobe 74 of the proximal extension 73, and the proximal extension 73 is inverted and placed inside the body 67 (here, the interior of the hollow push tube 30 is the body). In addition, the distal extension 76 is inverted and placed inside the proximal extension 73, thereby having an axial opening 63 extending through it. The anterior balloon 35 will be provided, where the push tube 30 is attached to the anterior balloon 35 and communicates with the interior of the anterior balloon 35. Importantly, the axial opening 63 is sized to receive the distal end of the endoscope 10 inside. Also important is the process mentioned above by flipping the proximal extension 73 into the body 67 and further flipping the distal extension 76 into the proximal extension 73. Thereby forming the anterior balloon 35 provides a plurality of layers of balloon material around the push tube 30, thereby providing a balloon configuration with higher robustness. In particular, providing multiple layers of balloon material around the push tube 30 adds cushioning to the distal end of the push tube 30, thereby pushing the distal tip with higher non-traumatic properties. It will be provided to the tube 30 and further ensures that the distal tip of the push tube 30 does not damage adjacent tissue.

In a preferred embodiment of the invention, the anterior balloon 35 is formed from polyurethane.

When the anterior balloon 35 is in its contracted state, the material of the anterior balloon 35 substantially surrounds the distal end of the push tube 30 (during which the push tube 30 is still allowed to fluidize inside the anterior balloon 35). Recognize that this provides a non-traumatic tip for advancing the anterior balloon 35 distally through the body lumen. In addition, the push tube 30 and the contracted anterior balloon 35, together as discussed further (FIG. 20), essentially function as leads with a soft tip for the device 5 and the endoscope 10. be able to.

If desired, one or both of the anterior balloon 20 and the posterior balloon 35 may be attached with an indicator (eg, a color indicator or an X-ray opaque indicator), resulting in or through the endoscope 10 or X-ray guidance. A physician (or other operator or user) observing the surgical site by (eg, X-ray fluoroscopy) can confirm the placement of one or both of these balloons at the surgical site. ..

The inflating mechanism 40 provides a means for selectively inflating the rear balloon 20 and / or the anterior balloon 35.

In a preferred embodiment of the invention, and also with reference to FIGS. 1 and 11, the expansion mechanism 40 comprises a linear syringe inserter 140 with a body 145 and a plunger 150. Preferably, a spring 153 is provided in the body 145 to automatically return the plunger 150 to the end of its stroke. The syringe inserter 140 is connected to one or the other of the fittings 46, 56 via a line 155. Therefore, when using such a configuration, if a linear syringe inserter 140 is to be used to inflate the rear balloon 20, the syringe inserter 140 is connected to the fitting 46 via a line 155. As a result, the output of the linear syringe inserter 140 is guided to the rear balloon 20 (ie, via the proximal expansion / contraction tube 45). Correspondingly, if a linear syringe inserter 140 would be used to inflate the anterior balloon 35, the syringe inserter 140 would be connected to the fitting 56 via line 155, resulting in a linear syringe. The output of the syringe 140 is guided to the anterior balloon 35 (ie, through the hollow interior of the flexible tube 59 and the push tube 30).

In another preferred embodiment of the invention, the expansion mechanism 40 comprises an elastic spherical portion 156 having a first port 157 and a second port 158. A one-way valve 159 (eg, a check valve) is located within the first port 157 so that air can only pass through the first port 157 when moving outward. Another one-way valve 159 (eg, a check valve) is located within the second port 158 so that air can only pass through the second port 158 when moving inward. When the elastic sphere 156 is compressed (eg, by hand), the air inside the elastic sphere 156 is pushed out of the first port 157, and then when the elastic sphere 156 is released, the air is second. It is pulled back into the elastic spherical portion 156 through the port 158 of the.

If, as a result of this configuration, the elastic spherical portion 156 would be used to inflate the rear balloon 20, the first port 157 would be connected to the fitting 46 via the line 155, resulting in an elastic spherical portion. The positive pressure output of portion 156 is guided to the rear balloon 20. The elastic spherical portion 156 can then be used to contract the posterior balloon 20, i.e., by connecting the second portion 158 to the fitting 46 via a line 155, the attractive force of the elastic spherical portion 156 is rearward. It is guided by the balloon 20. Correspondingly, if the elastic sphere 156 would be used to inflate the anterior balloon 35, the first port 157 would be connected to the fitting 56 via the line 155, resulting in the elastic sphere 156. The output of positive pressure is guided to the anterior balloon 35. The elastic spherical portion 156 can then be used to contract the anterior balloon 35, i.e., by connecting the second port 158 to the fitting 56 via the line 155, the attractive force of the elastic spherical portion 156 is forward. It is guided by the balloon 35.

Alternatively, and then with reference to FIGS. 12 and 13, the syringe 160 can be used to inflate the posterior balloon 20 and / or the anterior balloon 35. The expansion mechanism 160 includes a body 161 and a plunger 162. Preferably, a spring (not shown) is provided in the body 161 to automatically return the plunger 162 to the end of its power stroke. The syringe 160 is connected to the fittings 46, 56 via the line 163. When using this configuration, the syringe 160 comprises a valve 165 for connecting the syringe 160 to the anterior balloon 35 or the posterior balloon 20, and a valve 170 for selecting expansion or contraction of the connected balloon.

Therefore, when using this configuration, if the syringe 160 is to be used to inflate the rear balloon 20, the valve 165 (a two-position valve connecting the valve 170 to either the anterior balloon or the posterior balloon) The syringe 160 is set to connect to the rear balloon 20 through the fitting 46, and the valve 170 (one-way valve is arranged to inflate in one configuration and contract in the other configuration). The bidirectional crossover valve) is configured to provide expansion pressure by the syringe 160. After that, when the rear balloon 20 is to be contracted, the valve 170 is set to come to the contracted position.

Correspondingly, if the syringe 160 would be used to inflate the anterior balloon 35, the valve 165 would be configured to connect the syringe 160 to the anterior balloon 35 through the fitting 56. , The valve 170 is configured to provide expansion pressure by the syringe 160. After that, when the anterior balloon 35 is to be contracted, the valve 170 is set to come to the contracted position.

In yet another embodiment of the invention, the expansion mechanism 40 can include an automatic fluid pressure source (either positive or negative pressure), such as an electric pump.

If desired, and then with reference to FIG. 14, the relief valve 175 is inflated / connected to the anterior balloon 35 to ensure that the pressure in the anterior balloon 35 does not exceed a predetermined level. Can be connected to a shrink line. Similarly, further referring to FIG. 14, the relief valve 180 is on the expansion / contraction line connected to the rear balloon 20 to ensure that the pressure in the rear balloon 20 does not exceed a predetermined level. Can be connected.

Alternatively and / or in addition, one or more pressure gauges 182 (FIG. 1 or 13) are incorporated into the fluid line connected to the rear balloon 20 and / or the fluid line connected to the anterior balloon 35. Obtained, thereby providing the physician (or other operator or user) with information about the pressure inside the posterior balloon 20 and / or the anterior balloon 35, thereby avoiding excessive swelling and / or the procedure. Helps the doctor (or other operator or user) check the inflated state of the balloon inside.

Further, when the anterior balloon 35 moves between its "backward" position (FIG. 2) and its "extended" position (FIG. 4), the push tube 30 can be connected to the base 25 (and thus the fitting 56). It will be appreciated that the flexible tubing 59 can collect around the base 25, thereby potentially interfering with the movement of the physician (or other operator or user). Therefore, if desired, and then with reference to FIG. 15, a flexible tube retraction system 185 may be provided to remove slack in the flexible tube 59 as the anterior balloon 35 is stretched (eg, for example. In the base 25).

(Preferable way to use new equipment)
The device 5 better presents the side wall tissue for examination and / or treatment during an endoscopic procedure using the endoscope 10 (area initially hidden from or outside the field of view). Distal tip of an instrument (eg, grasper, cutter or anatomical instrument, cautery tool, ultrasonic probe, etc.) that has been advanced into the treatment zone, for example (including visualization of) and / or, for example. And / or to manipulate the body cavity and / or the side walls of the body cavity for the purpose of stabilizing the working edge (eg, stabilizing, straightening, inflating, and / or flattening, etc.) Can be used.

More specifically, at the time of use, the sleeve 15 is first installed on the endoscope 10 (FIG. 1). This pulls the base 25 proximally over the distal end of the endoscope 10 until this substantially aligns the distal end of the sleeve 15 with the distal tip of the endoscope 10 and then endoscopy. This can be achieved by pulling proximally along the length direction of the mirror 10. At this point, the posterior balloon 20 is deflated, the anterior balloon 35 is deflated, and the anterior balloon 35 is united over the distal end of the endoscope 10. The endoscope 10 and device 5 are ready to be inserted into the patient as a unit.

Next, referring to FIG. 16, the endoscope 10 and the device 5 are inserted as a unit into the body lumen and / or the body cavity of the patient. For example, but not limited to, the endoscope 10 and device 5 are inserted as units into the patient's gastrointestinal (GI) tract. The endoscope 10 and device 5 are advanced along the body lumen and / or the body cavity to the desired location within the patient (FIGS. 17 and 18).

When device 5 is to be used (eg, for the purpose of improving visibility of the side wall of the gastrointestinal tract and / or for improving access to the side wall, and / or with reference to the side wall. The posterior balloon 20 is inflated to stabilize the device 5 (and thus the endoscope 10) in the body lumen and / or the body cavity (to manipulate the side wall of the gastrointestinal tract) for the purpose of stabilizing the instrument. NS. See FIG. This can be done using the coupled expansion mechanism 40 mentioned above.

In this regard, because the connecting portion of the endoscope is on the distal side of the posterior balloon 20, even after the posterior balloon 20 is inflated, the endoscope is posterior to facilitate visualization of the biological structure. It will be recognized that it can be articulated on the distal side of the balloon 20. Importantly, such because the posterior balloon 20 stabilizes the endoscope 10 in the gastrointestinal tract and widens the colon to a fixed diameter that is directly adjacent to the posterior balloon 20. Visualization is improved.

The push tube handle 37 is then pushed distally to advance the push tube 30 distally within the body and / or body cavity (ie, the anterior balloon 35 further anterior to the posterior balloon 20). To move). Therefore, the push tube 30 and thus the anterior balloon 35 move distally with respect to the endoscope 10 (which is stabilized in place in the gastrointestinal tract by the inflated posterior balloon 20). During such distal advancement of the anterior balloon 35, the contracted anterior balloon 35 covers the distal end of the push tube 30, thereby ensuring that the anterior balloon 35 advances non-traumatically. Please note that. It should be noted that the non-traumatic advancement of the anterior balloon 35 can be further improved by forming the distal end of the push tube 30 from a material with higher elasticity.

When the push tube 30 advances the anterior balloon 35 to a desired position on the distal side of the endoscope 10, the anterior balloon 35 is inflated (FIG. 20), thereby anchoring the anterior balloon 35 to the biological structure. Again, this can be done using the coupled expansion mechanism 40 mentioned above. When the anterior balloon 35 is inflated, the inflated anterior balloon 35, the inflated posterior balloon 20 and the push tube 30 are all complementary to each other, thereby during an endoscopic procedure using the endoscope 10. Of the body cavities and / or body cavities for the purpose of better presenting the side wall tissue for examination and / or treatment (including visualization of areas initially hidden from or outside the field of view). Stabilize the sidewalls, straighten, inflate, and / or flatten. In this regard, the inflated anterior balloon 35 and the inflated posterior balloon 20 both inflate and / or tension the side wall of the body cavity, and the anterior balloon is distal to the posterior balloon. It will be appreciated that when stretched to, the push tube 30 will tend to straighten the anatomy between the two inflated balloons. Also, in this regard, when both the posterior balloon 20 and the anterior balloon 35 are inflated, the anterior balloon 35 forms a substantially full diameter seal over the body lumen and / or the body cavity (its). The reason is that the inflated anterior balloon closes the axial opening 63 extending through the anterior balloon when in its contracted state), and the posterior balloon 20 cooperates with the sleeve 15 and the endoscope 10. It will be recognized that this will form another barrier of substantially all diameters over the body lumen and / or the entire body cavity. Thus, the inflated anterior balloon 35 and the inflated posterior balloon 20 both define a substantially closed area along the body cavity and / or the body cavity (ie, established by the inflated anterior balloon 35 and the posterior balloon 20). An isolated treatment zone that prevents the passage of fluids and / or other liquids by an airtight seal). The inflating of the anterior balloon 35 and the posterior balloon 20 causes tension in the body lumen and / or the side walls of the body cavity, whereby the body lumen and / or the body cavity and / or for viewing through the endoscope 10 It will better present the side walls of the body cavity.

Inflating the body cavity and / or the side wall of the body cavity and applying tension to the side wall, realized by the inflated anterior balloon 35, the inflated posterior balloon 20 and the push tube 30, causes the anterior balloon to be inflated into the body. Recognizing that advancing the anterior balloon while grasping the lumen and / or the side wall of the body cavity can be further improved, thereby exerting more tension on the body cavity and / or the side wall of the body cavity. I want to be.

Importantly, because the inflated anterior balloon 35 and the inflated posterior balloon 20 both define a substantially closed area (ie, an isolated treatment zone) along the body cavity and / or body cavity. _{The region can then be inflated with fluid (eg, air, CO 2} , etc.) to further tension the body lumen and / or the side walls of the body cavity, thereby more. The body lumen and / or the side wall of the body cavity can be better presented and stabilized for visual recognition through the endoscope 10 to facilitate accurate therapeutic intervention. ..

If desired, the anterior balloon 35 can be retracted towards the posterior balloon 20 while maintaining its inflated state (and thus holding the body lumen and / or the side wall of the body cavity). (By pulling the push tube handle 37 proximally), thereby moving the visible mucosa to further improve visualization and access (see Figure 22), eg, thereby of the body lumen and / or body cavity. A particular target area on the side wall is positioned at a favorable angle relative to the endoscope and endoscopic tools.

Alternatively, if desired, when the posterior balloon 35 is inflated, the push tubes 30 can be moved distally over a portion (but only a portion) of their complete distal stroke. The anterior balloon 35 can then be inflated, thereby grasping the body lumen and / or the side wall of the body cavity, and then the push tube 30 can be advanced further distally. This action causes the flexible push tube 30 to flex outward (see FIGS. 22A-22D), allowing the body to come into contact with the body lumen and / or the side wall of the body cavity, eg, in the form of a "tent". It pushes the side walls of the lumen and / or body cavity outwards, thereby further improving the visibility of the body lumen and / or the side walls of the body cavity by the endoscope 10.

If desired, instrument 190 (FIG. 23) advances through the working channel of endoscope 10 to biopsy and / or treat the pathological condition (eg, to remove the pathological anatomy). Can be made to. These instruments, which are effectively stabilized relative to the biological structure via the rear balloon 20, will extend through the distal end of the endoscope, and as a result, the working end of the instrument 190 will also be relative to the biological structure. It will be recognized that it will be more stable. This is a great advantage over prior art practices such as advancing the instrument out of the unstable end of the endoscope. Preferably, the instrument 190 has an articulated instrument with full range of motion, which results in better access to the target anatomy.

In addition, if the bleeding obscures the tissue site or if the bleeding occurs and the surgeon cannot determine the source of the bleeding, the isolated treatment zone is the anatomy where the treatment zone is located. Allows rapid cleaning of the target segment (using a liquid such as salt water), followed by rapid removal of the cleaning fluid (see FIGS. 24-26).

Also, if desired, the anterior balloon 35 can be guided to the bleeding site with high accuracy, after which the anterior balloon 35 can be used to apply local pressure to the bleeding site to improve bleeding control (eg,). Can be inflated) (see Figure 27). This can be done under the visualization realized by the endoscope 10.

If it is desired to reposition the endoscope 10 within the biological structure with minimal interference from the device 5, the anterior balloon 35 is returned to its torus configuration (ie, partially contracted) and anterior. The balloon is retracted proximally to "reunite" onto the distal end of the endoscope 10, the posterior balloon 20 is contracted, and the endoscope 10 (along with the device 5 carried on it) has a biological structure. Relocated within. If the anterior balloon 35 is to be reunited over the distal end of the endoscope 10, the anterior balloon 35 is preferably partially reunited until the anterior balloon 35 is reunited over the distal end of the endoscope. Note that only shrinks. The reason is that the partial inflatation of the anterior balloon 35 allows the anterior balloon 35 to remain with sufficient "body" to facilitate the reunion process. The anterior balloon 35 can then be fully contracted if desired, thereby ensuring that, for example, the distal end of the endoscope 10 is gripped.

Alternatively, if desired, the anterior balloon 35 can be used as a drag brake to control the reverse movement of the endoscope. More specifically, in this embodiment of the invention, the endoscope 10 and device 5 are first united into the body lumen and / or body cavity until the tip of the endoscope is in the proper location. You can move forward. The posterior balloon 20 is then inflated, the push tube 30 is advanced distally, and the anterior balloon 35 is inflated (FIG. 28). Visualization and optional therapeutic treatment can then be performed at that location. If the device is to be moved in the opposite direction, the posterior balloon 20 is contracted, the anterior balloon 35 is partially contracted, the endoscope is retracted proximally, thereby the body cavity and / Alternatively, pull the semi-inflated anterior balloon 35 along the body cavity (FIG. 29), where the anterior balloon 35 acts as a brake when the endoscope is pulled proximally, thereby. It is possible to move the endoscope in the opposite direction in a more controlled manner, and by extension, it is possible to better visualize the biological structure. At some point, if desired, the posterior balloon 20 and the anterior balloon 35 can be reinflated as shown in FIG. 30, where the fluid is in an "isolated treatment zone" established between the two balloons. With or without introduction, thereby stabilizing, straightening, inflating, and / or flattening the biological structure.

It is also possible to use the rear balloon 20 alone or in combination with the braking motion mentioned above on the anterior balloon 35 as a brake when retracting the endoscope (and thus the device 5) from the biological structure. Is.

At the end of the procedure, the endoscope 10 and device 5 are retracted from the anatomy. Preferably, this retracts the push tube 30 so that it contracts (or partially contracts) the anterior balloon 35 and "reunites" the anterior balloon 35 onto the distal end of the endoscope 10 and anteriorly. The anterior balloon 35 is completely contracted so that the balloon 35 grips the distal end of the endoscope, the rear balloon 20 is contracted (if the rear balloon 20 is not yet contracted), and the endoscope This is done by retracting the biological structure with the 10 and the device 5 as a unit.

It should be recognized that the device 5 can advantageously be used in a variety of techniques other than those disclosed above. For example, if the endoscope 10 (and device 5) is to be advanced in the colon, the anterior balloon 35 is first projected distally under the visual guidance of the endoscope. As a result, the anterior balloon 35 is connected to the distal end of the endoscope. As a result, when the endoscope is advanced distally with the anterior balloon 35 contracted (or partially contracted), the anterior balloon and the flexible push tube 30 pass through the colon. It can function as a non-traumatic lead (guide structure) for the endoscope as the endoscope moves forward. Importantly, when the advancing anterior balloon 35 contacts the colon wall (eg, at the turning point of the colon) because the distal end of the push tube 30 is preferably highly flexible. ), The flexible push tube can be refracted, so that the anterior balloon can follow the path of the colon, thereby assisting the endoscope to advance non-traumatically along the colon. do. It is also recognized that device 5 can be advantageously used in other techniques to facilitate further examination of the luminal surface, which would otherwise be difficult to perform. I want to be. An example of this is endoscopic ultrasonography of the lumen as facilitated by the examination of a fluid-filled inflated anterior balloon and an ultrasonic probe.

(Additional configuration)
If desired, the devices 5 may be configured so that the push tube 30 can be advanced or retracted independently of each other and even simultaneously with each other, thus making the push tube 30 independent. Can assist in maneuvering a partially contracted or fully contracted anterior balloon 35 to pass through body cavities and / or body cavities by advancing or retracting. It can be facilitated to advance or retract the endoscope 10 so that it passes through the body cavities and / or the body cavities, and / or by thus advancing the push tube 30 independently. Alternatively, withdrawal can facilitate the application of "spinning force" to the biostructure using the inflated anterior balloon 35, thereby better presenting the biostructure for visualization and / or treatment. You will be able to.

For example, but not limited to, in this embodiment of the invention, and also with reference to FIG. 30A, each of the push tubes 30 is independently and slidably mounted on the push tube handle 37, resulting in the push tube. 30 will be able to move independently of the push tube handle 37 and even independently of each other. The stop portion 191 limits the distal movement of the push tube 30 relative to the push tube handle 37, so that the push tube cannot be moved completely out of the push tube handle 37. .. If the anterior balloon 35 is to be moved distally as a result of this configuration, the push tubes 30 are moved distally, either integrally or independently of each other. Further, when the anterior balloon 35 is to be moved to the proximal side, the push tube 30 is moved to the proximal side integrally or independently of each other. At any point in the procedure, the push tubes 30 can be moved independently of each other, for example when the anterior balloon 35 is inflated and engaged with the biological structure, thereby causing the anterior balloon to "swirl". Thereby applying a "swivel force" to the anatomy, such as when the anterior balloon 35 is used as a non-traumatic tip for an assembly that is partially inflated and advanced, in this case. Thereby, it assists in "manipulating" the assembly to pass through the biological structure. The push rod 30 is used for the purpose of preventing excessive turning of the front balloon 35 and / or crossing of the push rods and / or entanglement of the push rods and / or misalignment of the push rods. It should be noted that it may be desirable to provide a limiting mechanism to limit the extent to which they can be moved in the longitudinal direction independently of each other. It should also be noted that the push tube 30 can be held in a particular arrangement by placing the push tube 30 within the clamp 53 mentioned above (FIGS. 12 and 15).

Further, it should be recognized that it is possible to modify the configuration of the sleeve 15 to support the instrument (or hollow instrument guide tube) outside the endoscope 10. More specifically, with reference to FIGS. 5 and 6 again, in the configuration shown in FIGS. 5 and 6, the lumen for the sleeve 15 to receive the expansion / contraction tube 45 for inflating / contracting the rear balloon 20. It will be found that it comprises 47 and a pair of lumens 52 for receiving the support tube 50 for manipulating the anterior balloon 35 and for receiving the push tube 30 for inflating / contracting. However, if desired, the sleeve 15 can also have an additional lumen to support the instrument (or hollow instrument guide tube) outside the endoscope 10.

More specifically, with reference to FIG. 31, an end view of another form of the sleeve 15 having a plurality of lumens 195 for slidably receiving the instrument 190 inside is shown. The posterior balloon 20 provides a solid platform for maintaining the endoscope 10 and sleeve 15 in the body lumen or body cavity during inflating, where the endoscope 10 and sleeve 15 are in the body lumen or body cavity. Note that it is centrally located. As a result, the distal end of the lumen 195 of the sleeve 15 is also fixedly maintained within the body cavity or body cavity, thereby allowing the instrument to be advanced through the lumen 195 of the sleeve 15. It will provide a solid support.

The proximal end of lumen 195 may extend to base 25 and through base 25, in which case the instrument may be inserted into lumen 195 at base 25 or of lumen 195. The proximal end may be terminated proximal to the base 25 (still outside the patient's body), in which case the instrument can be inserted into the lumen 195 in the middle of the sleeve 15. For example, if the endoscope 10 is 180 cm long and the instrument 190 is 60 cm long, the instrument 190 is placed in the lumen 195 at a point closer to the balloons 20, 35 (not at the base 25), without limitation. It may be advantageous to insert it inside. In FIG. 31, this figure receives the expansion / contraction tube 45 because the lumen 47 and the expansion / contraction tube 45 point distally at a location distal to where they terminate on the sleeve 15. Note that the lumen 47 for and the expansion / contraction tube 45 for inflating / contracting the rear balloon 20 are not visible.

Figures 32-35 show various instruments 190 extending out of lumen 195. The instrument 190 is preferably an articulated instrument such as, for example, the Grasper 190A of FIGS. 32-35, the cauterization device 190B of FIGS. 32-33, the scissors 190C of FIGS. 34 and 35, and the suction device 190D of FIGS. 32-35. Please note that

The sleeve 15 has its central passage for receiving the endoscope 10, a lumen 47 for receiving the expansion / contraction tube 45, a lumen 52 for receiving the support tube 50 for receiving the push tube 30, and / or an instrument. It should be recognized that the sleeve 15 is preferably formed by an extrusion process when provided with a lumen 195 for slidably receiving the 190 inside.

In a preferred embodiment of the present invention, the lumen 47 for receiving the expansion / contraction tube 45, the lumen 52 for receiving the support tube 50 for receiving the push tube 30, and / or the instrument 190 are slidably received. The lumen 195 for this can have a fixed configuration (ie, a constant diameter), resulting in an outer profile to which the sleeve 15 is fixed.

In another preferred embodiment of the invention, the lumen 47 for receiving the expansion / contraction tube 45, the lumen 52 for receiving the support tube 50 for receiving the push tube 30, and / or the instrument 190 are slidable. The lumen 195 for receiving can have an expandable configuration (ie, it can have a minimal profile when empty and, if necessary, bulge diametrically upon filling), as a result. The overall profile of the sleeve 15 is minimized.

Further, if the sleeve 15 comprises a plurality of lumens 195 for slidably receiving the instrument 190 in, the distal end of the lumen 195 to improve the support of the instrument 190 received within the lumen 195. Recognize that it may be desirable to provide a high degree of structural integrity. For this purpose, a support ring may be provided at the distal end of the sleeve 15, where the support ring has an opening for the push tube 30 to pass through and an opening for the instrument 190 to pass through. I will provide a. It is noted that such an opening in the support ring for passing the instrument 190 preferably forms a tight fit with the instrument to better support the instrument at the distal end of the sleeve 15. sea bream.

Alternatively and / or in addition, the lumen 195 can accept a hollow instrument guide tube, in which the hollow instrument guide tube itself accepts the instrument. Such a hollow instrument guide tube can provide higher structural integrity to the distal end of the lumen 195 to improve the support of the instrument 190 received within the lumen 195. Also, such hollow instrument guide tubes can have fixed geometry, or can have bendable or articulated geometry. See, for example, FIG. 36 showing a hollow instrument guide tube 200 extending out of lumen 195 and receiving instrument 190 therein. It should be noted that the hollow instrument guide tubes 200 can be movable independently of each other (and can be moved independently of the sleeve 15). It should also be noted that the instrument 190 preferably forms a tight fit with the hollow instrument guide tube 200 to better support the instrument at the distal end of the sleeve 15.

Also, be aware that if desired, the two push tubes 30 may be replaced by a single push tube 30, or three or more push tubes 30, such as three push tubes 30. When a plurality of push tubes 30 are provided, it is generally desirable to arrange the push tubes evenly in the circumferential direction. For example, when two push tubes 30 are provided, the two push tubes 30 are generally separated by 180 degrees. When three push tubes 30 are provided, it is generally desirable that the push tubes be separated by 120 degrees.

(Tissue retreat and tissue recovery)
(Organizational recession)
In some situations, it may be necessary or desirable to detach the body lumen and / or the tissue within the body cavity. Not limited, for example, endoscopic submucosal dissection (ESD) as an endoscopic submucosal dissection for removing the intestinal lesion as a single section even when the intestinal lesion is very large. ). When using ESD, a cutting tool that passes through an endoscope (eg, an electrocautery knife equipped with an energy source) is used to detach the lesion directly along the submucosa of the intestine, thereby removing the lesion. Even large lesions can be safely peeled off at once.

There are many challenges with conventional ESD. For one thing, this technique uses a clear plastic cap that is placed over the tip of the endoscope to spread the submucosal fibers and assist in tissue detachment. It is sometimes accompanied by pushing inside. However, this technique partially obstructs the surgeon's view. In addition, fluid, debris, and vapor may typically accumulate in a clear plastic cap that sits above the tip of the endoscope, thereby further obstructing the surgeon's field of vision. ..

In addition to the above, ESD procedures are generally time consuming and often hours. Most of this time is often spent stripping the lesion along the submucosa of the intestine.

Similar problems can occur with other endoscopic tissue dissection procedures.

An endoscopic tissue retraction system for ESD procedures and other endoscopic tissue dissections provides surgeons with better visibility of the surgical field and speeds up the dissection process.

(Tissue recovery)
In addition to the above, after exfoliation of the lesion from the submucosa of the intestine, or after exfoliation of other tissue during endoscopic tissue ablation, the lesion (or other exfoliated tissue) It can be difficult to recover. This is due to (i) the technical challenge of keeping the exfoliated lesion (or other exfoliated tissue) in the intestine, and (ii) the exfoliated tissue (or other exfoliated tissue) using a recovery tool. ) Is the technical issue of grasping. In addition, exfoliated lesions (or other exfoliated tissue) with early cancer can contaminate disease-free areas of the intestine when moving through the intestine (eg, potentially cancerous cells). Seed with).

An endoscopic tissue retraction system for ESD procedures and other endoscopic tissue ablation allows surgeons to better control and anchor detached lesions in the intestine. do.

(Endoscopic tissue retraction system)
To this end, in a preferred embodiment of the invention, and then with reference to FIGS. 37-42, to provide the surgeon with better visualization of the surgical field, eg, during an ESD procedure, to speed up the detachment process. A novel device 5 used with the endoscopic tissue retraction system 300 is shown. In this embodiment of the invention, the connector 305 is secured to (i) anterior balloon 35 (or push tube 30) and (ii) lesion 315. This is to clip the connector 305 to the anterior balloon 35 (or push tube 30) with a surgical clip 320 and to clip the connector 305 to the lesion 315 with another surgical clip 320. Can be done by It should be recognized that the connector 305 and the surgical clip 320 can be delivered to the surgical site through the working channel of the endoscope 10 (or through the instrument lumen 195 of the device 5). With the connector 305 anchored to both the anterior balloon 35 (or push tube 30) and the lesion 315, the anterior balloon 35 can be advanced distally to tension the connector 305, thereby causing the lesion. The portion 315 is urged distally (ie, exerts a force). The cutting tool 325 can then be advanced out of the distal end of the endoscope 10 (or through the instrument lumen 195 of device 5) and along the submucosal layer 330 of the intestine 335. It can be used to detach the lesion 315. It should be recognized that after the lesion 315 has been detached from the submucosa of the intestine, the lesion 315 will remain constrained to the anterior balloon 35 by the connector 305 and the surgical clip 320.

In a preferred embodiment of the invention, the connector 305 has a loop material (eg, a loop made of extruded filament, or a loop made of braid, etc.). Alternatively, the connector 305 is a single strand material (eg, single strand made from extruded filament, single strand made from braid, single strand made from wire, single strand made from suture, etc.) Can have.

In a preferred embodiment of the invention, when the connector 305 is formed from an elastomeric material (eg, elastic filament, or elastic braid, etc.) and as a result the lesion 315 is cut from the submucosal layer 330 of the intestine 335, the connector. The 305 automatically takes up the slack in the connector 305. In another embodiment of the invention, the connector 305 may be formed from an inelastic flexible material. In another embodiment of the invention, the connector 305 may be formed from an inelastic rigid body material.

In one embodiment of the invention, the anterior balloon 35 is advanced distally to tension the connector 305, thereby urging (ie, applying) the lesion 315 distally. In an alternative form of the invention, and then with reference to FIGS. 43-45, when the connector 350 has an elastoma material, the connector 305 is secured to one or the other of the anterior balloon 35 and the lesion 315 and then unfolded. It can then be attached to the other of the anterior balloon 35 and the lesion 315 and then released, thereby attaching the lesion 315 distally without requiring any movement of the anterior balloon 35 in the distal direction. Momentum (that is, apply force). Alternatively, the connector 305 can be unfolded and then anchored (in the unfolded state) to the anterior balloon 35 and lesion 315 and then released, thereby requiring any movement of the anterior balloon 35 in the distal direction. The lesion 315 is urged distally (that is, a force is applied) without the need for.

In another embodiment of the invention, and then with reference to FIG. 46, the connector 305 can have a loop 340 with a variable length, eg, the loop 340 has a slipknot 345 with a tension end 350. Can be done. In this embodiment of the invention, with the connector 305 loosened, the connector 305 is clipped to the anterior balloon 35 (or push tube 30) using a surgical clip 320, and the connector 305 attaches another surgical clip 320. It is clipped to the lesion 315 using. The connector 305 is then tensioned (eg, by pulling the tension end 350 of the slipknot 345 using a tool that is advanced through the working channel of the endoscope 10 or the instrument lumen 195 of the device 5). This urges the lesion 315 distally (ie, applies force). The cutting tool 325 can then be advanced out of the distal end of the endoscope 10 (or through the instrument lumen 195 of device 5) and along the submucosal layer 330 of the intestine 335. It can be used to detach the lesion 315. It should also be recognized that after the lesion 315 has detached from the intestinal submucosa, the lesion 315 will remain constrained to the anterior balloon 35 by the connector 305 and the surgical clip 320.

In another embodiment of the invention, the connector 305 may have a loop 340 having a variable length, where the slipknot 345 and the tension end 350 have a length adjusting clip 355 and one or more tensions. Replaced by end 360. See FIG. 47. In this embodiment of the invention, loop 340 by pulling one or more tension ends 360 using a tool that is advanced through the working channel of endoscope 10 (or through instrument lumen 195 of device 5). Is given tension.

In some cases, and also with reference to FIG. 48, it is advantageous to provide a connector 305 with a substantially rigid ring 365 at its proximal end (ie, the lesion-side end). It may be. For example, if the connector 305 is in the form of a loop, the loop of the connector 305 can pass through the center of a substantially rigid ring 365. A substantially rigid ring 365 facilitates attachment of the connector 305 to the lesion 315 by, for example, facilitating clipping of the connector 305 to the lesion 315 using a surgical clip 320. be able to.

In some cases, it may be desirable to use multiple connectors 305 to connect the lesion 315 to the anterior balloon 35. This allows the distal tension to be applied to the lesion 315 with multiple orientation vectors at multiple attachment points, thereby detaching the lesion 315 from the submucosal 330 of the intestine 335. Can assist. See FIG. 49.

Alternatively, and then with reference to FIG. 50, if the connector 305 is in the form of a loop, a plurality of substantially rigid rings 365 may be installed in a single connector 305, these plurality of substantially rigid rings. A rigid ring 365 can be anchored at various locations on the lesion 315, thereby allowing distal tension to be applied to the lesion 315 with multiple orientation vectors at multiple attachment points. Alternatively, if the connector 305 is a loop, multiple surgical clips 320 can be used to anchor different segments of the loop to different locations in the lesion 315, thereby distant by multiple orientation vectors at multiple attachment points. It makes it possible to apply lateral tension to the lesion 315.

In one embodiment of the invention, the connector 305 is attached to the anterior balloon 35 (or push tube 30) in situ using a surgical clip 320. However, if desired, the connector 305 is manufactured (or at some other time before inserting the anterior balloon 35 into the body), the anterior balloon 35 (or one of the push tubes 30 or). It may be attached in advance to a plurality of push tubes). For example, but also with reference to FIGS. 51 and 52, the connector 305 may be pre-attached to the anterior balloon 35 using an eyelet or grommet-lined eyelet 370. ..

Also, in some situations, it may be possible to attach the anterior balloon 35 (or one of the push tubes 30) directly to the lesion 315 without using the connector 305. I want to be recognized. For example, but not limited to, one or more surgical clips 320 can be used to attach the anterior balloon 35 (or one of the push tubes 30) directly to the lesion 315. See, for example, FIG. 52A showing a surgical clip 320 that anchors the anterior balloon 35 directly to the lesion 315 without using the connector 305. Also see, for example, FIG. 52B, which shows a surgical clip 320 that attaches the push tube 30 directly to the lesion 315 without using the connector 305.

When the lesion 315 detaches from the submucosa 330 of the intestine 335 (or when other tissue detaches from that site within the body lumen), the detached tissue generally must be removed from the patient's body. Simply removing the new device 5 from the patient's body because the detached tissue is anchored to the anterior balloon 35 (or push rod 30) by one or more connectors 305 and / or surgical clips 320. This allows the detached tissue to be removed from the body, where the detached tissue is retracted from the patient's body when the anterior balloon 35 is retracted from the patient's body. However, this approach involves failing to place the surgical clip on the detached tissue, or the surgical clip on the anterior balloon (or push tube), for example, by the anterior balloon 35 (or push tube). There is a risk that the exfoliated tissue will be torn from 30). In addition, this approach essentially pulls the exfoliated tissue exposed along the length of the intestine (or other body lumen) when the new device 5 is retracted from the patient's body. Become. In this case, for example, if the exfoliated tissue has early cancer that can contaminate a disease-free area of the intestine (or other body lumen) (eg, potentially disseminate cancerous cells). It is a risk for the patient.

(Endoscopic tissue recovery)
For this purpose and also with reference to FIGS. 53-60, the anterior balloon 35 may have a flap 375 disposed within the central hole 380 of the anterior balloon 35. The flap 375 is configured as a result: (i) When the anterior balloon 35 is united on the endoscope 10, the flap 375 is captured between the endoscope 10 and the anterior balloon 35. (Ii) If the anterior balloon 35 is detached from the endoscope 10 and protrudes distally from the endoscope 10 and is fully inflated, the flap 375 is closed central hole 380 of the anterior balloon 35. Captured within (FIGS. 53 and 54); (iii) The anterior balloon 35 projects distally from the endoscope 10 and is partially contracted, resulting in the reopening of the central hole 380 of the anterior balloon 35. When the flap 375 is exposed (FIGS. 55 and 56), the flap 375 can be "pulled down" across the central hole 380 of the anterior balloon 35 (eg, advanced through the instrument lumen 195 of the endoscope 10 or device 5). (With a tool), thereby forming a concave pouch 385 in the central hole 380 of the anterior balloon 35, together with the peripheral portion of the anterior balloon 35 defining the central hole 380 (FIGS. 57 and 58). The concave pouch 385 is configured to receive the exfoliated tissue (FIGS. 59 and 60).

Thus, in this embodiment of the invention, the exfoliated tissue is manipulated after exfoliating the lesion 315 from the submucosa 330 of the intestine 335 (or after exfoliating other tissue from that site within the body lumen). And placed in the concave pouch 385 (eg, using a tool that is advanced through the work channel of the endoscope 10 or the instrument lumen 195 of the device 5), and then simply removes the new device 5 from the patient's body. The detached tissue can be easily and safely removed from the body by removal, where the detached tissue is retracted from the patient's body when the anterior balloon 35 is retracted from the patient's body. Note that this can be done when the detached tissue is still connected to the anterior balloon 35 (or push tube 30) via the connector 305 and / or the surgical clip 320. This approach also fails to place the surgical clip on the detached tissue, or the surgical clip on the anterior balloon (or push tube), for example, by the anterior balloon 35 (or push tube). Effectively eliminates the risk of tearing of exfoliated tissue from 30) and the risk of early cancer contaminating disease-free areas of the intestine (or other body lumens) (eg, potentially seeding cancerous cells) Reduce the risk of causing). The reason is that when the exfoliated tissue is retracted from the patient's body, the exfoliated tissue is protected within the concave pouch 385.

(Additional endoscopic tissue retraction)
It is also possible to tension the lesion 315 away from the endoscope 10 by a variety of other techniques (eg, for the purpose of detachment).

( Tensioning the lesion by connecting the lesion to the non-inflated portion of the anterior balloon 35 using one or more connectors and by moving the anterior balloon )
For example, but also with reference to FIG. 61, it is also possible to attach the anterior balloon 35 directly to the lesion 315 using the connector 305. In this embodiment of the invention, the anterior balloon 35 comprises an inflatable portion 36 and a non-expandable portion (eg, a non-expandable neck 38 portion), and the connector 305 uses, for example, a clip 320 to provide a non-expandable neck of the anterior balloon 35. It is passed through 38 parts and connected to the lesion 315. Pass the connector through a needle carrying the connector so that it passes directly through the non-inflated portion of the anterior balloon 35, or through a hole (or eyelet) formed within the non-inflated portion of the anterior balloon 35. By passing, the connector 305 is passed through the non-inflated portion of the anterior balloon 35 (eg, the non-inflated neck portion 38 of the anterior balloon 35). The free end of the connector 305 is then connected to the lesion 315 using, for example, a clip 320. In a preferred embodiment of the invention, the connector 305 is a suture strand. Before the device 5 is inserted into the patient's body, a strand of suture forming the connector 305 can be passed through the neck portion 38 of the anterior balloon 35 (or the non-inflated portion of the anterior balloon 35). Or recognize that after the device 5 has been inserted into the patient's body, a strand of suture can be passed through the neck portion 38 of the anterior balloon 35 (or another non-inflated portion of the anterior balloon 35). I want to be. Alternatively, the anterior balloon 35 may be manufactured with a connector 305 (eg, a strand of suture) preattached to the neck portion 38 of the anterior balloon 35 (or another non-inflated portion of the anterior balloon 35).

In use, the device 5 is pulled over the endoscope 10 and the combination of the endoscope 10 and the device 5 is advanced into the intestine 335, so that the endoscope 10 is proximal to the lesion 315. Seated in the immediate vicinity of, the posterior balloon 20 is inflated to stabilize the endoscope relative to the lesion, and the connector 305 is the neck portion 38 of the anterior balloon 35 (or another non-inflated portion of the anterior balloon 35). ), Connected to the lesion 315 by a clip 320, and the push tube 30 is moved distally to tension the lesion 315 and separate it from the endoscope 10. A cutting tool 325 advanced through the working lumen (or instrument lumen 195) of the endoscope 10 is then used to detach the lesion 315 from the submucosal 330 of the intestine 335.

If desired, multiple connectors 305 can be passed through the non-inflated portion of the anterior balloon 35 and can be used to connect the lesion 315 to the anterior balloon 35. For example, with one or more connectors 305 attached to the lesion 315 (eg, with one or more clips 320), multiple suture strands are attached to the neck of the anterior balloon 35, without limitation. It can be passed through 38 (or other non-inflated portion).

Alternatively, a clip (eg, clip 320) is used to clip the connector 305 to the non-inflated portion of the anterior balloon 35 (eg, the non-inflated neck portion 38 of the anterior balloon 35), and then the connector 305 is clipped to the lesion 315. It is also possible to connect to. In addition, a plurality of connectors 305 can be clipped to the non-inflated portion of the anterior balloon 35 and used to connect the lesion 315 to the anterior balloon 35.

In another embodiment of the invention, and then with reference to FIGS. 62-65, the first connector 305 may be connected to the anterior balloon 35 (eg, the neck portion 38 of the anterior balloon 35 (or another non-inflation). By passing the connector 305 through (part) and clipping the connector 305 to the non-inflated portion of the anterior balloon 35), the second connector 305 is (i) the first connector 305, and (ii). ) Can be connected to lesion 315, thereby forming an extension loop 305A extending from the first connector 305.

The extension loop 305A is particularly useful when the lesion is located in the immediate vicinity of the proximal side of the proximal colonic turn. For example, if, but not limited to, the lesion 315 (eg, a polyp) is located in the immediate vicinity of the proximal side of the prominent turning part of the colon (eg, of the hepatic bend, splenic bend, or other colon). Connect the anterior balloon 35 to the lesion 315 (eg, using the connector 305 and clip 320), and then advance the anterior balloon 35 distally in the colon (near the proximal side of the curve). It may be difficult to apply tension to the lesion 315 by causing it. More specifically, if the lesion 315 is located in the immediate vicinity of the proximal side of the prominent turning part of the colon, the turning when the anterior balloon 35 is moved distally within the colon. The colon wall at the site is pressed to apply tension to the lesion (see FIG. 62). The device 5 can be advanced into a straight portion of the colon in order to prevent the anterior balloon 35 from pressing against the colon wall, resulting in an anterior balloon 35 (a first attached to the anterior balloon 35). (Along with connector 305) is placed distal to the turning part of the colon and the posterior balloon 20 is placed proximal to the turning part of the colon (see FIG. 63). The second connector 305 is then advanced into the colon, where one end of the second connector 305 is connected to the proximal side of the lesion 315 (eg, endoscopic clip 320). (See FIG. 64), the other end of the second connector 305 is connected to the first connector 305 (eg, using the second endoscope clip 320). Formed an extension loop 305A (see FIG. 65). At this point, the anterior balloon 35 can be pushed distally along the straight section of the colon to the extent necessary to provide the desired tension to the lesion 315.

If desired, the anterior balloon 35 is located distal to the diversion of the colon and the lesion 315 is located in the immediate vicinity of the proximal side of the prominent diversion of the colon. One connector 305 and a second connector 305 may be replaced with a single connector that is long enough to extend between the anterior balloon 35 and the lesion 315.

In another embodiment of the invention, the device 5 can be formed without the instrument lumen 195. In this embodiment of the invention, the tool can be passed along one or more working lumens of the endoscope. Alternatively, an endoscope having a diameter smaller than the diameter of the lumen of the sleeve 15 can be used, resulting in a space between the inner wall of the lumen of the sleeve 15 and the outer portion of the endoscope. In this case, one or more tools may be passed through the space between the sleeve 15 and the endoscope 10.

( Tensioning the lesion by connecting it to the tensioning tool and by moving the tensioning tool )
As a further example, but not limited to, and then with reference to FIG. 66, the tensioning tool 400 can be advanced to the surgical site through the instrument lumen 195 (or the working lumen of the endoscope 10) of the device 5, eg, a lesion. It can be used to urge the lesion 315 for the purpose of exfoliating the site. As shown in FIG. 66, the tensioning tool 400 can be directly engaged with the lesion 315 to grip the lesion 315, or the tensioning 400 can (eg, via clip 320). Note that the connector 305 can be gripped by engaging with the connector 305, which itself is anchored to the lesion 315. Alternatively, the tensioning 400 can be engaged with the connector 305 connected to the rigid ring 365 to grip the connector 305 (FIGS. 48-50), where the rigid ring 365 is secured to the lesion 315. (For example, via clip 320).

In use, the device 5 is pulled over the endoscope 10 and the combination of the endoscope 10 and the device 5 is advanced into the intestine 335, so that the endoscope 10 is proximal to the lesion 315. Seated in the immediate vicinity of, the posterior balloon 20 is inflated to stabilize the endoscope relative to the lesion, and the anterior balloon 35 is inflated to seal between the posterior balloon 20 and the anterior balloon 35. A zone is created and the tensioning tool 400 is advanced through the instrument lumen 195 (or the working lumen of the endoscope 10) into the treatment zone to grab the lesion 315 and move the tensioning tool 400. It gives tension to the lesion 315. The cutting tool 325, advanced through the working lumen (or instrument lumen 195) of the endoscope 10, is then used to detach the lesion 315 from the submucosal 330 of the intestine 335 (see FIG. 66). ..

In another embodiment of the invention, the device 5 can be formed without the instrument lumen 195. In this embodiment of the invention, the tensioning tool 400 can be passed along the working lumen of the endoscope. Alternatively, an endoscope having a diameter smaller than the diameter of the lumen of the sleeve 15 can be used, resulting in a space between the inner wall of the lumen of the sleeve 15 and the outer portion of the endoscope. In this case, the tensioning tool 400 can be passed through the space between the sleeve 15 and the endoscope 10 and fixed to the lesion 315.

In some situations, it may be desirable to apply tension to the lesion without creating a closed treatment zone between the two inflated balloons (eg, deploying an inflated anterior balloon and an inflated posterior balloon). Without). In such situations, it may be possible to use a simplified version of the device 5 mentioned above with the endoscope 10 mentioned above and the tensioning tool 400 mentioned above.

Device 5 can be simplified by eliminating the anterior balloon 35 mentioned above, for example, if it is desirable to apply tension to the lesion without creating a closed treatment zone between the two inflated balloons. In this simplified form of the device 5, the tensioning tool 400 can be used to tension the lesion (see FIG. 66A). This pulls the device 5 in a simplified form over the endoscope 10 and advances the combination of the endoscope 10 and the simplified device 5 into the intestine 335, causing the endoscope 10 to be lesioned. Sit in the immediate vicinity of the proximal side of 315 and inflate the posterior balloon 20 to stabilize the endoscope relative to the lesion and follow the instrument lumen 195 (or the working lumen of the endoscope 10). The tensioning tool 400 was advanced to engage the lesion 315 to tension the lesion 315 and the cutting tool 325 (eg, advanced through the working lumen or instrument lumen 195 of the endoscope 10). It can be done by using to detach the lesion 315 from the submucosal layer 330 of the intestine 335.

As a further example, but not limited to, the device 5 can be further simplified by eliminating the anterior balloon 35 mentioned above and the push tube 30 mentioned above, and this further simplified form of the device 5 is a lesion. Can be used to tension the balloon (see Figure 66B). More specifically, this pulls the device 5 in a more simplified form over the endoscope 10 to advance the combination of the endoscope 10 and the more simplified device 5 into the intestine 335. The endoscope 10 is seated in the immediate vicinity of the proximal side of the lesion 315, and the posterior balloon 20 is inflated to stabilize the endoscope with reference to the lesion, and the instrument lumen 195 (or endoscope) is used. The tensioning tool 400 is advanced along the working lumen of the mirror 10) to engage the lesion 315 to tension the lesion 315 and the cutting tool 325 (eg, the working lumen or instrument lumen of the endoscope 10). This can be done by exfoliating the lesion 315 from the submucosal 330 of the intestine 335 using (advanced through 195).

As a further example, but not limited to, the device 5 can be further simplified by eliminating the rear balloon 20 mentioned above and even the anterior balloon 35 mentioned above and the push tube 30 mentioned above, further simplification of this. A device 5 in the above form can be used to tension the lesion (see FIG. 66C). Thus, in this more simplified form of the invention, the device 5 essentially comprises a sleeve 15 and an instrument lumen 195. Upon use, tension can be applied to the lesion in the following form: this more simplified form of the device 5 is pulled over the endoscope 10 and the endoscope 10 and this further simplified device 5 The combination is advanced into the intestine 335, so that the endoscope 10 sits in the immediate vicinity of the proximal side of the lesion 315 and advances the tensioning tool 400 along the instrument lumen 195. It was engaged with the lesion 315 to tension the lesion 315 and then advanced through a cutting tool 325 (eg, the working lumen of the endoscope 10) to detach the lesion 315 from the submucosal 330 of the intestine 335. ) Is used.

As a further example, but not limited to, device 5 further by eliminating the instrument lumen 195 mentioned above, the rear balloon 20 mentioned above, and the anterior balloon 35 mentioned above and the push tube 30 mentioned above. It can be simplified and this further simplified form of the device 5 can be used to tension the lesion. Thus, in this more simplified form of the invention, the device 5 essentially comprises a sleeve 15 over the endoscope, where the diameter of the endoscope is smaller than the lumen of the sleeve lumen. It is sized so that a space is created between the inner wall of the lumen of the sleeve 15 and the outer portion of the endoscope. Upon use, tension can be applied to the lesion in the following form: this more simplified form of the device 5 is pulled over the endoscope 10 and the endoscope 10 and this further simplified device 5 The combination is advanced into the intestine 335, so that the endoscope 10 is seated in the immediate vicinity of the proximal side of the lesion 315 and is ten between the sleeve and the endoscope. The cutting tool 325 (eg, of the endoscope 10) is used to advance the shocking tool 400 to engage the lesion 315 to tension the lesion 315 and then detach the lesion 315 from the submucosal layer 330 of the intestine 335. (Advanced through the working lumen or through the space between the sleeve and the endoscope) is used.

( Tensioning the lesion by connecting the lesion to a bridge on a pair of push tubes and by moving the push tube )
As a further example, but not limited to, and then with reference to FIG. 67, another embodiment of the device 5 is shown, in which the anterior balloon 35 is excluded. In this embodiment, the distal ends of the push tube 30 of the sleeve 15 can be connected to each other by a bridge 31, the connector 305 can be attached to the bridge 31, and a clip 320 can be used to connect to the lesion 315. Preferably, the connector 305 is a strand of suture. A strand of suture forming the connector 305 can be attached to the bridge 31 before the device 5 is inserted into the patient's body, or after the device 5 is inserted into the patient's body. Recognize that a strand of thread can be attached to the bridge 31. Alternatively, the bridge 31 can be manufactured with a connector 305 (eg, a strand of suture) pre-attached to the bridge 31.

For example, in the technique shown in FIG. 68, the bridge 31 may be tilted distally. Alternatively, if desired, for example in the technique shown in FIG. 69, the bridge 31 can be set to be substantially perpendicular to the longitudinal axis of the push tube 30. Further, if desired, the bridge 31 may be in the form of a ring, for example in the technique shown in FIG. The bridge 31 may have any other shape or configuration in which the endoscope can be nested and / or connected to the connector 305. If desired, the bridge 31 may be formed to have a recess or recess within the bridge (not shown) for seating the connector 305, whereby the bridge 31 is tensioned when tensioning the lesion 315. Minimize sliding of connector 305 along.

Upon use, this simplified form of the device 5 is pulled over the endoscope 10 and the combination of the endoscope 10 and the simplified device 5 is advanced into the intestine 315, resulting in the inside. The endoscope 10 is seated in the immediate vicinity of the proximal side of the lesion 315, the posterior balloon 20 is inflated, thereby stabilizing the endoscope relative to the lesion, and the connector 305 is the bridge 31 of the push tube 30. Attached to and connected to the lesion 315 by a clip 320, the push tube 30 is moved distally to tension the lesion 315 away from the endoscope 10. A cutting tool 325, advanced through the working lumen (or instrument lumen 195) of the endoscope 10, is then used to detach the lesion 315 from the submucosal 330 of the intestine 335.

Alternatively, if desired, only one push rod 30 may be provided and the connector 305 (eg, a strand of suture) may be attached to one push rod 30.

As a further example, but not limited to, device 5 can be further simplified by eliminating the posterior balloon 20 mentioned above and even the anterior balloon 35 mentioned above, and this further simplified form of device 5 lesions. Can be used to tension the lesion. Thus, in this more simplified form of the invention, the device 5 essentially comprises a sleeve 15, an instrument lumen 195, and a push tube 30 (see FIG. 71). Upon use, the lesion may be tensioned in the following form: this further simplified device 5 is pulled over the endoscope 10 and the endoscope 10 and this further simplified form of the device 5 The combination is advanced into the intestine 335, so that the endoscope 10 sits in the immediate vicinity of the proximal side of the lesion 315 and connects the connector 305 from the bridge 31 of the push tube 30 to the lesion 315. The push tube 30 is moved to connect and tension the lesion 315, and then through the cutting tool 325 (eg, through the working lumen of the endoscope 10) to detach the lesion 315 from the submucosal 330 of the intestine 335 or (Advanced through instrument lesion 195) is used.

As a further example, but not limited to, the device 5 can be further simplified by eliminating the instrument lumen 195 mentioned above, the rear balloon 20 mentioned above, and even the anterior balloon 35 mentioned above, which is even simpler. A device 5 in a modified form can be used to tension the lesion. Thus, in this more simplified form of the invention, the device 5 comprises essentially a sleeve 15 above the endoscope and a push tube 30. Upon use, tension can be applied to the lesion in the following form: this more simplified form of the device 5 is pulled over the endoscope 10 and the endoscope 10 and this further simplified device 5 The combination is advanced into the intestine 335, so that the endoscope 10 sits in the immediate vicinity of the proximal side of the lesion 315 and connects the connector 305 from the bridge 31 of the push tube 30 to the lesion 315. The push tube 30 is moved to connect and tension the lesion 315, and then advance through the cutting tool 325 (eg, the working lumen of the endoscope 10) to detach the lesion 315 from the submucosal 330 of the intestine 335. Was made to use).

If the sleeve 15 is formed so that it does not have an instrument lumen 195, the tool is passed along one or more working lumens of the endoscope. Alternatively, an endoscope having a diameter smaller than the lumen diameter of the sleeve 15 may be used and one or more tools may be passed through the space between the sleeve 15 and the endoscope 10.

(Use)
Therefore, the present invention better presents side wall tissue for examination and / or treatment during an endoscopic procedure (including visualization of areas initially hidden from or outside the field of view). Including the provision and use of new devices for manipulating the body cavity and / or the side walls of the body cavity for the purpose of, for example, straightening the curved portion to "wrinkle" the folds on the surface of the lumen. The aim is to create a substantially stationary or stable side wall of the body cavity and / or body cavity, thereby allowing a more accurate visual examination (initially hidden from or outside the field of view). It can be seen that (including visualization of the area in) and / or therapeutic intervention is possible. For example, a novel device can be used to stabilize, straighten, inflate, and / or flatten curves and / or curves and / or folds within the side wall of the intestine, thereby. Better present side wall tissue for examination and / or treatment during endoscopic procedures (including visualization of areas initially hidden from or outside the field of view).

The present invention also relates to an instrument (eg, an endoscope, a grasper, or a cutter) that is inserted into the body lumen and / or the body cavity relative to the body lumen and / or the side wall of the body cavity during an endoscopic procedure. Or new capable of fixing and / or stabilizing the distal tip and / or working edge of articulated and / or non-articulated devices such as anatomical instruments, ablation tools, and ultrasound probes. Includes the provision and use of various devices, thereby facilitating the accurate use of those instruments.

For example, the device is a stable platform (ie, stable endoscope, stable treatment tool, and stable) for performing many minimally invasive procedures within the body lumen and / or body cavity. The colon wall (all of which are stable to each other) can be provided, for example, lesion biopsy and / or lesion removal procedures, organ resection procedures, endoscopic submucosal dissection (ESD). ), Endoscopic mucosal reduction (EMR), etc., endoscopic and / or other surgical instruments (eg, grasper, cutter or dissection instrument, cautery) in the body cavity and / or body cavity Stabilizing the colon (including reducing deformation of the colon wall) with the aim of stabilizing tools, ultrasound probes, etc., while allowing for more accurate visualization, intervention and / or surgery. ) Is included.

Importantly, the present invention can fix and / or stabilize the distal tip and / or working end of the endoscope relative to the body lumen and / or the side wall of the body cavity. Can (and thus the distal tip and / or working edge of other instruments, such as graspers, cutters or anatomical instruments, cauterizing tools, ultrasonic probes, etc., inserted through the working channel of such an endoscope. It can also be fixed and / or stabilized) and provides a novel device capable of stabilizing the body lumen and / or the side wall of the body cavity with reference to these instruments.

The present invention also describes the distal tip and / of instruments (graspers, cutters or anatomical instruments, cauterizing tools, ultrasonic probes, etc.) that can be advanced to the surgical site by means other than through the working channel of the endoscope. Alternatively, a novel device capable of fixing and / or stabilizing the working end is provided.

The novel device of the present invention is an endoscope (and / or) based on the tissue to facilitate alignment and presentation of the tissue during an endoscopic procedure. To stabilize the working edge of (another instrument that can be advanced through the endoscope), or to assist in advancing the endoscope during such a procedure, virtually any endoscope Can be used in a surgical procedure.

The present invention generally features a number of diversions and has side walls characterized by numerous folds and the course of the disease identified on and between these folds, a gastrointestinal (GI) tube (eg, for example). , Large intestine and small intestine, esophagus, stomach, etc.). However, the methods and devices of the invention are also inside other body cavities (eg, blood vessels, lymph vessels, ureters, fallopian tubes, bronchi, bladder, etc.) and / or other body cavities (eg, head). It can also be used inside the abdomen, chest, abdomen, ureter, bladder, cavities in organs, etc.).

(Correction)
Although the present invention has been described in the context of preferred embodiments of specific embodiments, the invention is not limited to these preferred embodiments of specific embodiments, and while remaining within the scope of the invention. It will be readily appreciated and recognized by those skilled in the art that many additions, exclusions and modifications may be made to the preferred embodiments discussed above.

Claims (44)

A device for endoscopically retracting tissue
The device
With a sleeve that is fitted to slide over the outer part of the endoscope,
A balloon that is movably installed on the sleeve,
It comprises at least one connector extending from the balloon, which is configured to be anchored to the tissue to be retracted.
A device configured such that the balloon is moved relative to the sleeve to retract the tissue. The device of claim 1, wherein the balloon comprises an inflatable portion and a non-expandable portion, and the at least one connector is connected to the non-expandable portion. The device of claim 2, wherein the at least one connector is connected to the non-inflated portion of the balloon using a clip. 2. The second aspect of the invention, wherein the at least one connector is connected to the non-inflated portion of the balloon by passing the at least one connector through a hole in the non-inflated portion of the balloon. Device. The device of claim 1, wherein the at least one connector is attached to the tissue using a clip. The device of claim 1, wherein the at least one connector has a loop. The device of claim 1, wherein the at least one connector has a single strand. The device according to claim 1, wherein the at least one connector includes a first connector and a second connector. The device according to claim 8, wherein the second connector is attached to the first connector using a first clip and attached to the tissue using a second clip. The first connector has a loop, and the second connector is connected to the first connector by looping the second connector so as to pass through the loop of the first connector. , The apparatus according to claim 8. The device of claim 1, wherein the balloon is movably installed in the sleeve by at least one push tube. A method for endoscopically retracting tissue,
The method comprises providing a device for endoscopically retracting tissue.
The device
With a sleeve that is fitted to slide over the outer part of the endoscope,
A balloon that is movably installed on the sleeve,
It comprises at least one connector extending from the balloon, which is configured to be anchored to the tissue to be retracted.
The above method
Positioning the endoscope placed within the sleeve so that it is adjacent to the tissue to be retracted,
To attach the at least one connector to the balloon and the tissue to be retracted,
A method further comprising retracting the tissue away from the endoscope by moving the balloon away from the endoscope. 12. The method of claim 12, wherein the balloon comprises an inflatable portion and a non-inflated portion, and the at least one connector is connected to the non-inflated portion. 13. The method of claim 13, wherein the at least one connector is connected to the non-inflated portion of the balloon using a clip. 13. The thirteenth aspect of the invention, wherein the at least one connector is connected to the non-inflated portion of the balloon by passing the at least one connector through a hole in the non-inflated portion of the balloon. Method. 12. The method of claim 12, wherein the at least one connector is attached to the tissue using a clip. 12. The method of claim 12, wherein the at least one connector has a loop. 12. The method of claim 12, wherein the at least one connector has a single strand. 12. The method of claim 12, wherein the at least one connector comprises a first connector and a second connector. 19. The method of claim 19, wherein the second connector is attached to the first connector using a first clip and to the tissue using a second clip. The first connector has a loop, and the second connector is connected to the first connector by looping the second connector so as to pass through the loop of the first connector. , The method of claim 19. 12. The method of claim 12, wherein the balloon is movably installed in the sleeve by at least one push tube. 12. The method of claim 12, wherein the tissue to be retracted comprises a lesion. 23. The method of claim 23, wherein the lesion is attached to the submucosa of the intestine. A device for endoscopically retracting tissue
The device
With a sleeve that is fitted to slide over the outer part of the endoscope,
A device comprising a tensioning tool extending through the sleeve, which is configured to be anchored to tissue to be retracted. 25. The device of claim 25, wherein the sleeve comprises at least one instrument lumen and the tensioning tool is allowed to pass through the at least one instrument lumen to retract tissue. Because the endoscope is further provided and the diameter of the endoscope is smaller than the diameter of the instrument lumen so that there is a space between the sleeve and the endoscope and the tensioning tool retracts the tissue. 25. The apparatus according to claim 25, which allows the space to pass through the space. A method for endoscopically retracting tissue,
The method comprises providing a device for endoscopically retracting tissue.
The device
With a sleeve that is fitted to slide over the outer part of the endoscope,
It comprises a tensioning tool that extends through the sleeve, which is configured to adhere to the tissue to be retracted.
The above method
Positioning the endoscope placed within the sleeve so that it is adjacent to the tissue to be retracted,
Connecting the tensioning tool to the tissue to be retracted
A method further comprising retracting the tissue by moving the tensioning tool relative to the endoscope. 28. The method of claim 28, wherein the sleeve comprises at least one instrument lumen and the tensioning tool is allowed to pass through the at least one instrument lumen to retract tissue. The diameter of the endoscope is smaller than the diameter of the instrument lumen, so that there is a space between the sleeve and the endoscope that allows the tensioning tool to pass through the space to retract tissue. 28. The method of claim 28. A device for endoscopically retracting tissue
The device
With a sleeve that is fitted to slide over the outer part of the endoscope,
A pair of push tubes that are slidably installed on the sleeve, wherein the pair of push tubes are connected to each other using a bridge at their distal ends.
It comprises at least one connector extending from the bridge, which is configured to be anchored to the tissue to be retracted.
A device in which the pair of push tubes are configured to be moved relative to the sleeve for the purpose of retracting the tissue. 31. The device of claim 31, wherein the at least one connector is attached to the bridge using a clip. 31. The device of claim 31, wherein the at least one connector is attached to the bridge using a loop. 31. The device of claim 31, wherein the at least one connector is attached to the tissue using a clip. 31. The device of claim 31, wherein the at least one connector has a loop. 31. The device of claim 31, wherein the at least one connector has a single strand. 31. The device of claim 31, wherein the bridge is in the form of a ring. A method for endoscopically retracting tissue,
The method comprises providing a device for endoscopically retracting tissue.
The device
With a sleeve that is fitted to slide over the outer part of the endoscope,
A pair of push tubes that are slidably installed on the sleeve, wherein the pair of push tubes are connected to each other using a bridge at their distal ends.
It comprises at least one connector extending from the bridge, which is configured to be anchored to the tissue to be retracted.
The method is to position the endoscope placed in the sleeve so that it is adjacent to the tissue to be retracted.
At least fixing the connector to the pair of push tubes and the tissue to be retracted.
A method further comprising retracting the tissue away from the endoscope by moving the pair of push tubes relative to the endoscope. 38. The method of claim 38, wherein the at least one connector is attached to the bridge using a clip. 38. The method of claim 38, wherein the at least one connector is attached to the bridge using a loop. 38. The method of claim 38, wherein the at least one connector is attached to the tissue using a clip. 38. The method of claim 38, wherein the at least one connector has a loop. 38. The method of claim 38, wherein the at least one connector has a single strand. 38. The method of claim 38, wherein the bridge is in the form of a ring.

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